Calming & Regeneration Care

Care-program menu guide

Calming & Regeneration Care

Calming & Regeneration Care is not one product — it is a clinic-assigned heading over several separately named items: an LED regeneration laser, calming care, regeneration care, and post-hair-removal calming. Each item carries a different amount of public record. The LED device holds an FDA 510(k) clearance (K223544) as a Class II device, cleared on nonclinical safety and biocompatibility data, with indications that differ by wavelength and never use the word regeneration. A systematic review of light therapy for skin rejuvenation pooled 57 mostly preclinical studies and found no malignancy signal on its oncologic-safety question, while its own authors describe the underlying clinical evidence as a narrative synthesis with real methodological limits. Calming care and regeneration care are program names the clinic has assigned to a bundle of steps, so what each one specifically includes — and how closely that matches the post-light/laser aftercare literature discussed on this page — is worth confirming item by item.

Published Last updated Medically reviewed by Duk-ha Kim
What the heading bundles
LED regeneration laser, calming care, regeneration care, post-hair-removal calming — separately named items on one menu heading
LED device clearance
FDA 510(k) K223544, Class II, cleared on nonclinical data; indications differ by wavelength and never use the word regeneration
Light-therapy evidence base
One systematic review pooling 57 studies (41 in vitro, 9 animal, 7 clinical) as a narrative synthesis, not a meta-analysis
What to confirm at consultation
Which wavelength the LED step uses, and what is actually applied or performed under calming care and regeneration care

What is actually being sold under this single menu heading?

Several separately named items bundled by the clinic into one heading — an LED regeneration laser, calming care, regeneration care, and post-hair-removal calming. None of the sources checked for this page treats that heading as a single product with one mechanism or one evidence base. Each item carries a different amount of public record: the LED device has a clearance letter that can be read line by line, while calming care and regeneration care are step names rather than named devices. So the useful starting question is not “does this program work” but “what does each named item actually consist of, and how much of that has been examined.”

Abstract editorial visualization for Calming & Regeneration Care consultation planning
Sources: Abijou editorial visualization (AI-generated)Explanatory AI-generated illustration; not an actual patient photograph.

Sources: FDA 510(k) K223544 — LED light therapy device clearance, indications by wavelength

What did the FDA actually clear for the LED device behind this menu item?

A specific 510(k) clearance, filed under number K223544, covering an LED light-therapy device as a Class II product. The clearance groups indications by wavelength rather than assigning one blanket claim to the whole device, so “LED” alone does not name a single indication — the wavelength used determines what the clearance actually covers. What the letter does not contain is any indication phrased around “regeneration”; that word is absent from the cleared language, no matter how a menu item built around the device is named. Reading a 510(k) number off a menu is a starting point, not an endpoint — the next question is which wavelength this specific step uses, since that is what the clearance actually speaks to.

Sources: FDA 510(k) K223544 — LED light therapy device clearance, indications by wavelength

Do all LED wavelengths on this kind of device carry the same indication?

No — the clearance assigns a different indication to each wavelength rather than one indication to the device as a whole. Red light is cleared for temporary reduction of fine lines and wrinkles across the face; blue light is cleared for mild-to-moderate inflammatory acne; infrared light is cleared for local heating, temporary relief of minor muscle and joint pain, and temporarily increasing local blood circulation; and a combined mode is cleared for acne. None of those four wavelength-specific indications is phrased as skin regeneration, tissue repair or cell renewal — regeneration is menu vocabulary, not clearance vocabulary. The practical question at this level is which colour of light a session actually uses, since red, blue, infrared and combined are four different clearances, not four names for one effect.

Sources: FDA 510(k) K223544 — LED light therapy device clearance, indications by wavelength

Was that clearance based on a clinical trial measuring a skin outcome?

No — the clearance file for K223544 records its supporting data as nonclinical and states that clinical data is not applicable to the submission. What supported the clearance instead were electrical-safety testing under IEC 60601 and biocompatibility testing under ISO 10993 — engineering and materials standards confirming the device will not electrically or chemically harm the user, not standards that measure whether skin looks different afterward. A 510(k) clearance of this kind is a finding of substantial equivalence to an already-marketed device, not an independent trial of the newly cleared unit, so no efficacy study specific to this device sits behind the K223544 number, on regeneration or on anything else.

Sources: FDA 510(k) K223544 — LED light therapy device clearance, indications by wavelength

How does the FDA classify photobiomodulation devices more broadly, and how settled is that classification?

As Class II devices requiring premarket notification, and that classification is stated to extend to the PBM component of a device even when it is combined with electrical-stimulation, massage or ultrasound functions in the same unit — a combination device does not skip PBM-specific review just because it also does something else. That framing comes from an FDA document aimed at manufacturers preparing 510(k) submissions for this device family. Its own status label matters: it is dated January 2023, marked as a draft, described as non-binding, and carries the explicit instruction “not for implementation.” A draft guidance describes the agency’s current thinking on how to prepare a submission; it is not a clearance, a rule, or evidence that any specific device — including the one behind this menu item — has completed that review.

Sources: FDA — Photobiomodulation (PBM) devices: premarket notification 510(k) submissions (draft guidance)

What does the published evidence on light-based skin treatment actually cover?

A systematic review published in Aesthetic Surgery Journal, whose stated purpose was evaluating the oncologic safety of low-level light therapy for aesthetic skin rejuvenation, pooled 57 studies in total — 41 laboratory (in vitro) studies, 9 animal studies and 7 clinical studies. Working through that pooled set, the reviewers reported that the included work was associated with increases in collagen and elastin production and with reported improvements in wrinkle appearance and skin texture. Those are real reported findings, and they are the closest thing to a summary of efficacy literature relevant to a menu item like this. What has to be read alongside them is what kind of review this is and how much of the underlying set was actually clinical rather than laboratory or animal work — the next section takes that up directly.

Sources: Aesthetic Surgery Journal 2023;43(5):NP357 — systematic review of the oncologic safety of low-level light therapy for aesthetic skin rejuvenation

How strong is that evidence, methodologically, once the headline numbers are set aside?

Considerably weaker than a headline count of 57 studies suggests, and the review’s own authors say so. The 57 studies were synthesised narratively rather than combined in a quantitative meta-analysis; the authors state directly that the light parameters used across studies were too heterogeneous to pool into a single quantitative estimate. Most of the seven clinical studies in that set are described as methodologically weak — single-centre trials and case series rather than large, blinded, multicentre randomised trials — and the longest follow-up reported across the reviewed clinical work was 12 months, with most studies shorter. None of that means the reported collagen, elastin, wrinkle or texture findings are false — it means they come from an early and heterogeneous evidence base, not a settled one.

Sources: Aesthetic Surgery Journal 2023;43(5):NP357 — systematic review of the oncologic safety of low-level light therapy for aesthetic skin rejuvenation

How long does the effect from the LED or light-based steps in this bundle actually last?

The longest follow-up reported anywhere in the light-therapy evidence discussed on this page is 12 months, and most of the studies inside that pooled review followed participants for less time than that — so twelve months is the outer edge of what has been checked, not a typical or guaranteed duration. That figure comes from the same systematic review that reported collagen and elastin increases and improved wrinkle appearance, and its own authors describe the underlying clinical evidence as a narrative synthesis of mostly single-centre trials and case series rather than a body of replicated, controlled work — so even the twelve-month figure sits on weaker footing than a plain number suggests. The FDA clearance behind the LED device does not add anything to this question at all: it rests on nonclinical electrical-safety and biocompatibility testing, not a clinical trial measuring a skin outcome, so no efficacy timeline of any length comes from the clearance itself. Nothing in the sources checked for this page reports what happens to collagen, elastin or wrinkle appearance after twelve months, and nothing establishes how many sessions or what interval is needed to reach or maintain whatever change a course of sessions produced. What decides how long any visible change actually holds — the wavelength and dose used, how many sessions were completed, and each person’s own skin turnover — is not quantified in the evidence behind this bundle. The consultation question that follows is what specific study or clearance the clinic is pointing to when it describes a lasting result, and whether that source measured duration at all or only measured safety.

Sources: Aesthetic Surgery Journal 2023;43(5):NP357 — systematic review of the oncologic safety of low-level light therapy for aesthetic skin rejuvenationFDA 510(k) K223544 — LED light therapy device clearance, indications by wavelength

What does that same review say about adverse events and cancer risk specifically?

Its stated focus was oncologic safety, and on that specific question it did not identify a malignancy signal across the pooled studies — no case of skin cancer or another malignant outcome attributed to the light therapy in question is reported. On more routine adverse events, the review cites mild erythema in three of sixteen participants in one included study, and a separate report of one case of transient redness that resolved within a week in another. No serious adverse event beyond those mild, self-limited skin reactions is reported. Those figures come from individual small studies inside the pooled set rather than a large safety database, so read them as the available signal, not as a comprehensive safety profile.

Sources: Aesthetic Surgery Journal 2023;43(5):NP357 — systematic review of the oncologic safety of low-level light therapy for aesthetic skin rejuvenation

What does the name “calming care” or “regeneration care” actually tell you, and what should you ask?

“Calming care” and “regeneration care” are names the clinic has given to a bundle of steps inside this program, so the name itself works like the label on a box rather than a list of its contents. Asking what is inside is the useful move: what is physically applied or performed under each name — a sunscreen, a serum, a device step, a massage-like step — and whether that content matches the post-procedure literature discussed elsewhere on this page, since that literature only applies where it actually describes what is done. The same logic applies to “post-hair-removal calming”: ask whether it is the same calming step offered elsewhere on the menu at a different time, or a distinct step with its own contents. Naming a bundled program is an ordinary part of how a clinic organises its menu; treating the name itself as a list of confirmed contents is the step worth skipping.

What does the evidence say about sun protection after a light- or laser-based step?

A narrative review of the English-language literature, searching MEDLINE, PubMed and Ovid between 2000 and 2024, on sunscreen use after light- and laser-based procedures. It reports physical, mineral sunscreens containing zinc oxide or titanium dioxide, at SPF 30 or higher, as the option favoured after these procedures, associated in the reviewed literature with reduced post-procedure pigmentation change and redness compared with leaving skin unprotected. Read the review type carefully: this is a narrative review, not a systematic review with a formal search-and-screening protocol, and its own authors describe most of the underlying evidence as case series and observational studies rather than controlled trials — the evidence level behind the recommendation is acknowledged by the authors themselves to be low. A sunscreen recommendation for post-light and post-laser skin generally is not the same statement as a proven outcome for the specific step named “calming care” here; it is background context for what an evidence-informed aftercare routine looks like.

Sources: Narrative review — sunscreen use after light- and laser-based procedures (MEDLINE/PubMed/Ovid, 2000-2024)

What does the post-laser moisturising serum case series actually show?

A single case series, not a controlled trial, following eight people (n=8) who applied an adaptogenic moisturising serum after a laser procedure, with no comparison group receiving a different product or no product. The report was retrospective and relied on participants’ own assessment of their skin rather than an independent clinical measurement, and it found that 87% of participants experienced the reactions ordinarily expected after a laser procedure — redness, swelling, crusting — before those reactions improved. Every one of those design features narrows what the figure can support: eight people is too small a group to generalise from, no control group means the serum’s specific contribution cannot be separated from normal post-laser healing, and self-assessment is a softer measure than an examiner’s grading. This page does not extend that 87% figure, or any expectation from this case series, to describe “calming care” or “regeneration care” in general.

Sources: Case series — post-laser application of an adaptogenic moisturising serum (n=8, no control group)

Does “post-hair-removal calming” follow the same aftercare principles as other light- or laser-based steps?

It sits inside the same general timing logic: a calming step scheduled for right after a procedure that can leave skin more reactive, in this case hair removal specifically. The two aftercare sources discussed on this page — the sunscreen literature and the serum case series — both concern the period after a light- or laser-based procedure in general, so the practical move is to confirm how closely this specific item follows that same logic: is it a physical sunscreen, a specific serum, or a device step, and how soon after the hair-removal session is it performed. Confirming those details lets the post-procedure evidence above be matched against what is actually offered under this name, rather than assumed from the label.

Sources: Narrative review — sunscreen use after light- and laser-based procedures (MEDLINE/PubMed/Ovid, 2000-2024)Case series — post-laser application of an adaptogenic moisturising serum (n=8, no control group)

Does a Class II clearance tell you where or by whom a device can be used?

Only part of the picture. A Class II clearance under a system like the FDA’s establishes that a device requires premarket notification and that its accepted uses are the wavelength-specific indications named in the clearance; it is a US market-entry record, so it does not by itself state operator licensing or clinic registration rules in Korea or any country outside its own jurisdiction. “This device is Class II in the US” and “this specific unit is registered for use where you are being treated, by this operator” are two separate facts, and the second is the one worth asking the clinic directly, alongside the model name and the wavelength used for this particular session.

Sources: FDA 510(k) K223544 — LED light therapy device clearance, indications by wavelengthFDA — Photobiomodulation (PBM) devices: premarket notification 510(k) submissions (draft guidance)

What is worth asking about each named item before booking?

Treat the heading as several separate questions rather than one. For the LED step: which wavelength is used — red, blue, infrared or combined — since each carries a different cleared indication, and ask for the device’s clearance or registration number. For calming care and regeneration care: ask what is physically applied or performed under each name — a sunscreen, a serum, a device, a massage-like step — because the program name specifies none of that, and the post-procedure literature discussed above only applies if it actually matches what is done. For post-hair-removal calming: ask whether it is the same calming step as elsewhere on the menu at a different time, or a distinct step with its own contents, and how soon after the hair-removal session it takes place.

What is worth settling with the clinic before this program is booked?

Settle identity, evidence level and sequence, in that order. First, get the specific wavelength behind the LED step and what is actually applied or performed for calming care and regeneration care, since a menu heading names none of that on its own. Second, ask the clinic to be specific about what is established for each item rather than accepting the umbrella program name as a stand-in for evidence: the LED clearance is nonclinical and wavelength-specific with no regeneration wording in it, the wider PBM literature is a narrative synthesis of mostly small and short clinical work, and the post-procedure sunscreen and serum sources describe general aftercare and one small case series, not a validated outcome for this named program. Third, if hair removal is part of the visit, ask what the calming step afterward specifically consists of and how soon it follows the session. None of this is a reason to avoid booking; it is the minimum information needed to know what has actually been examined about what you are booking, and to keep a figure like the case series’ 87% correctly attached to the small, uncontrolled study that produced it rather than to the program as a whole.

Sources: FDA 510(k) K223544 — LED light therapy device clearance, indications by wavelengthAesthetic Surgery Journal 2023;43(5):NP357 — systematic review of the oncologic safety of low-level light therapy for aesthetic skin rejuvenationNarrative review — sunscreen use after light- and laser-based procedures (MEDLINE/PubMed/Ovid, 2000-2024)Case series — post-laser application of an adaptogenic moisturising serum (n=8, no control group)

Several named items, one heading — what is confirmed for each, and what should you confirm directly?

This table does not ask whether the program works. It sorts what public record exists for each named item sold under one heading, and pairs it with what to ask the clinic directly. The rows draw on documents of different kinds and different strength, so no row ranks above another.

Several named items, one heading — what is confirmed for each, and what should you confirm directly?
Menu itemWhat the name suggestsWhat a primary source confirmsWhat to confirm with the clinic
LED regeneration laserA light-based device positioned as restoring or renewing skinFDA 510(k) K223544, Class II, cleared on nonclinical data (IEC 60601 electrical safety, ISO 10993 biocompatibility); indications differ by wavelength — red for facial wrinkles, blue for mild-to-moderate inflammatory acne, infrared for local heat/muscle-joint pain relief/circulation, combined for acneWhich wavelength this specific session uses, and whether the unit is registered for use where you are being treated
Calming careA soothing step, often positioned after another procedureGeneral post-light/laser literature associates SPF 30+ physical sunscreen (zinc oxide/titanium dioxide) with less post-procedure pigmentation change and redness, per a narrative review whose authors describe the underlying evidence as mostly case series and observationalWhat is actually applied under this name — the sunscreen described above, a different product, or a device step
Regeneration careA step implying tissue renewal or repairA systematic review of light-based skin rejuvenation reports collagen/elastin increases and wrinkle/texture improvement across 57 pooled studies (41 in vitro, 9 animal, 7 clinical), with no malignancy identified on its oncologic-safety questionWhether this step uses light therapy at all, and if so, which wavelength and device
Post-hair-removal calmingA calming step timed to follow hair removal specificallyThe same general post-light/laser sunscreen literature above, plus a small case series (n=8, no control group, self-assessed) in which 87% of participants had expected post-laser reactions that then improvedWhat this step specifically applies, and how soon after the hair-removal session it takes place

A record that says less about a component describes what has been published about it, not whether the component helps or harms. A device clearance based on nonclinical data has not been reviewed for efficacy on skin appearance either way. Confirm directly with the clinic which device, product or protocol each named step actually uses.

Sources: FDA 510(k) K223544 — LED light therapy device clearance, indications by wavelengthFDA — Photobiomodulation (PBM) devices: premarket notification 510(k) submissions (draft guidance)Aesthetic Surgery Journal 2023;43(5):NP357 — systematic review of the oncologic safety of low-level light therapy for aesthetic skin rejuvenationNarrative review — sunscreen use after light- and laser-based procedures (MEDLINE/PubMed/Ovid, 2000-2024)Case series — post-laser application of an adaptogenic moisturising serum (n=8, no control group)

Medical care at Abijou

Care is provided by the medical team at the branch you select. These clinicians lead the three branches linked from this guide; confirm the doctor assigned to your visit with that branch.

Duk-ha Kim Chief MD, Gangnam

Chief MD, Gangnam

Duk-ha Kim

The trust our patients have placed in this clinic was built on conviction and principle. We intend to hold to both, unchanged, through the next hundred years.

Cheol-su Yoon Chief MD, Myeongdong

Chief MD, Myeongdong

Cheol-su Yoon

I want to be thinking about how the patient feels right up to the last moment of the procedure.

Jae-wook Kim Chief MD, Hongdae

Chief MD, Hongdae

Jae-wook Kim

I will give my best with the attentiveness to catch even the smallest change.

Listed branch medical team — not a medical-review byline for this article.

Frequently asked questions

Is this program a single treatment, or several different things bundled together?

Several different things bundled together — the menu groups an LED regeneration laser, calming care, regeneration care and post-hair-removal calming under one heading, and each of those items has a different amount of public record behind it.

Does the FDA’s LED clearance mention skin regeneration?

No — the cleared indications are organised by wavelength (red for facial wrinkles, blue for mild-to-moderate acne, infrared for local heat and pain relief and circulation, combined for acne), and none of them uses the word regeneration; that framing comes from the menu name rather than the clearance letter, K223544.

Was the LED device tested in a clinical trial before it was cleared?

No — its 510(k) file lists its supporting data as nonclinical, based on electrical-safety testing (IEC 60601) and biocompatibility testing (ISO 10993), and states directly that clinical data is not applicable to that submission.

Is the FDA’s guidance on photobiomodulation devices a finalised rule?

No — it is a draft guidance dated January 2023, explicitly labelled non-binding and “not for implementation,” so it describes the agency’s current thinking on how manufacturers should prepare a submission rather than a completed regulatory action.

How much clinical, human research actually sits behind the collagen and wrinkle claims made for light therapy?

A relatively small slice of a larger pooled review — the systematic review behind these claims pooled 57 studies in total, of which only 7 were clinical studies, alongside 41 in vitro and 9 animal studies, and the review’s authors describe most of that clinical subset as methodologically weak.

Did that review find a cancer risk from this kind of light therapy?

No malignancy was identified across the pooled studies, since the review’s stated question was the oncologic safety of low-level light therapy, and on that specific question it did not report a case of skin cancer or another malignant outcome attributed to the treatment.

What side effects does the light-therapy literature actually report?

Mild, self-limited skin reactions in a small number of participants — one included study reported mild erythema in three of sixteen participants, and a separate report described one case of transient redness that resolved within a week, with no serious adverse event reported beyond those.

What should I ask about the calming and regeneration steps before booking?

What is actually applied or performed under each name — since program names like these describe a bundle the clinic has put together rather than a single product, ask specifically whether a sunscreen, a serum, a device, or a massage-like step is used, and how that matches the post-light/laser aftercare evidence described on this page.

Is “calming care” or “regeneration care” a standard clinical term?

They are program names the clinic has assigned to a bundle of steps, not terms drawn from a device classification or a medical-society guideline — so the useful move is to ask what is actually applied or performed under each name, since the label alone specifies neither the product used nor its evidence level.

What does the evidence say about applying sunscreen after a light- or laser-based step?

A narrative literature review associates physical sunscreens containing zinc oxide or titanium dioxide, at SPF 30 or higher, with less post-procedure pigmentation change and redness, though the review’s own authors describe most of the underlying studies as case series and observational work rather than controlled trials.

Does the post-laser serum case series prove that a soothing serum speeds recovery?

No — it is a single case series of eight people with no control group and self-assessed outcomes, reporting that 87% had the reactions ordinarily expected after a laser procedure before those reactions improved, which is too small and too uncontrolled a study to generalise into a proven recovery effect.

Is there a professional-society protocol specifically for calming skin after hair removal?

“Post-hair-removal calming” follows the same general post-light/laser aftercare logic as other steps on this page — a physical sunscreen, possibly a soothing product, applied around the timing of the hair-removal session — so the useful question is what specifically is used and how soon after the session it is applied.

Does a Class II FDA clearance tell you who is allowed to operate the device, or where?

Not by itself — a Class II clearance establishes that a device needed premarket notification and names its accepted wavelength-specific indications, but it says nothing about operator licensing or clinic registration in Korea or any country outside its own jurisdiction, which is a separate question for the clinic.

What should be confirmed before booking this program?

The specific wavelength behind the LED step, and what is actually applied or performed for calming care and regeneration care — because the evidence behind each differs sharply, from a nonclinical device clearance to a narrative review to a single small case series, and none of it is interchangeable with the others.

How Abijou works

We started in Gangnam in 2006 and the network now runs 17 branches across Korea. The line we work to is skin transformation woven into everyday life — care you can keep up with, rather than one dramatic change.

  • Across the 17 branches in Seoul, Gyeonggi, Incheon and Busan: over 1,000 medical professionals and more than 350 certified medical devices
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Calming & Regeneration CareContact & booking