Seoul
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.
Infrared lamp treatment guide
Titan
Titan is an infrared light device made by Cutera. In the United States it is cleared under 510(k) K042165 (2004-10-18) as an infrared lamp under 21 CFR 890.5500, with indications covering local heating, temporary relief of minor muscle and joint pain and stiffness, arthritis-related relief, increased local blood circulation and muscle relaxation — tightening and lifting are not part of that list. Two independent studies on an infrared device have examined change in skin laxity, but that evidence does not rewrite the wording of the cleared indications.
- Manufacturer
- Cutera
- Energy
- Infrared light filtered to roughly 0.8–2.0 µm, paired with contact cooling — not a laser, RF or HIFU device
- U.S. FDA record
- 510(k) K042165, decided 2004-10-18, product code ILY, regulated under 21 CFR 890.5500 as an infrared lamp
- Cleared indications
- Local heating; temporary relief of minor muscle and joint pain and stiffness; arthritis-related relief; increased local blood circulation; muscle relaxation — no tightening or lifting wording
What is Titan, and who makes it?
Titan is an infrared light device manufactured by Cutera. In the United States, the record that is the source for this page is 510(k) K042165, decided 2004-10-18. That record is the starting point for everything else described here: what kind of energy the device delivers, how U.S. regulators classify it, and what it is cleared to do.
Sources: FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for use
Which type of energy does Titan use?
Titan delivers infrared light filtered to a band of roughly 0.8 to 2.0 micrometers, applied together with contact cooling at the skin surface. That is a different energy category from a laser, which emits coherent light at a single wavelength, from radiofrequency, which uses electrical current, and from HIFU, which uses focused ultrasound. The source cited on this page describes the device in these terms; it does not publish a treatment depth or a temperature figure.
Sources: FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for use
How is Titan classified in the U.S. FDA’s 510(k) database?
In the FDA’s 510(k) database, Titan (Cutera) is cleared under K042165, decided 2004-10-18, product code ILY, regulated under 21 CFR 890.5500. That regulation covers infrared lamps — a device category built around delivering infrared energy for warming — rather than a category created for cosmetic skin-tightening devices.
Sources: FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for use
What does the FDA clearance list as Titan’s indications for use?
The record lists these indications: providing local heating for the purpose of elevating tissue temperature, temporary relief of minor muscle and joint pain and stiffness, temporary relief of joint pain associated with arthritis, temporary increase in local blood circulation, and relaxation of muscles. Read line by line, none of it is a tightening or lifting claim.
Sources: FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for use
Does a 510(k) clearance approve a specific marketing claim?
No — a 510(k) clearance is a determination that a device is substantially equivalent to another device already legally marketed for the same indications; it is not an approval of a marketing phrase. K042165 was decided for Titan through that process, and the substantial-equivalence finding attaches to the device and to the indications printed on that record, not to whichever word a clinic later chooses for advertising a session.
Sources: FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for use
Why is “tightening” not part of the cleared indications?
Because the indications printed on the clearance record concern pain relief, circulation and muscle relaxation, not a change in the appearance of skin laxity. If a Titan session is advertised with a word such as tightening or lifting, that word is coming from the clinic’s own marketing rather than from the FDA record described above — it is worth asking the clinic directly which claim they are making and what it is based on.
What role does contact cooling play in the device?
The device is used with contact cooling applied at the skin surface during treatment, alongside the infrared energy. Beyond that pairing, the source cited on this page does not publish a target temperature, a treatment depth or a cooling duration, so ask the clinic operating the device how they set and monitor these parameters for your session.
Sources: FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for use
How does an infrared lamp differ from a laser, RF or HIFU device?
An infrared lamp is one of several distinct energy categories used in skin and tissue treatments; laser, radiofrequency and HIFU devices are each regulated under their own separate product codes and indications. The FDA record cited on this page classifies Titan specifically as an infrared lamp under 21 CFR 890.5500 — it does not set that classification against a laser, RF or HIFU device, so a comparison between them has to be built from each device’s own record.
Sources: FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for use
What did the split-face study on an infrared device find?
A split-face, single-blind study evaluated an infrared device using one side of the face as the treated side and the other as an untreated control, following 13 participants for three months. The investigators reported a statistically significant difference between the treated and control sides (p=0.031) — a result from a small trial, with only 13 participants, rather than a large confirmatory one.
Sources: Study — split-face, single-blind evaluation of an infrared device (n=13, 3-month follow-up)
What did the case-series study on an infrared device find?
A case series followed 25 participants treated with an infrared device for skin laxity, with follow-up extending up to 12 months. The series had no control group, so the changes reported in these 25 participants cannot be separated from changes that might have occurred over the same period without treatment.
Sources: Case series — infrared device for skin laxity (n=25, follow-up up to 12 months)
What limits should be kept in mind for both studies?
Both studies cited on this page are independent — neither lists a co-author affiliated with the device manufacturer — but both carry the limits that come with small research: 13 participants in the split-face study and 25 in the case series, with no control group at all in the case series. Results from studies of this size describe what was observed in those specific participants; they are a starting point rather than a large randomized trial, and they should be read that way.
Sources: Study — split-face, single-blind evaluation of an infrared device (n=13, 3-month follow-up)Case series — infrared device for skin laxity (n=25, follow-up up to 12 months)
Does the existence of these studies change the wording of the FDA clearance?
No. A 510(k) clearance is a fixed regulatory record tied to the filing the FDA reviewed and decided — K042165, decided 2004-10-18 for Titan — and it changes only through a new FDA filing, not through later journal publications. The split-face study and the case series cited on this page were published after that clearance and examine change in skin laxity, but they sit alongside the indications on the FDA record; they do not edit the wording of that record.
Sources: FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for useStudy — split-face, single-blind evaluation of an infrared device (n=13, 3-month follow-up)Case series — infrared device for skin laxity (n=25, follow-up up to 12 months)
How long does the effect last?
The two studies cited on this page are the only material for discussing duration, and each covers a different length of time. The split-face study followed 13 participants for three months and found a statistically significant difference between the treated and untreated side at that point (p=0.031) — evidence that a difference was still detectable at three months, not a statement about how long it continues after that. The case series followed 25 participants for up to twelve months, but it had no control group, so any change recorded that far out cannot be separated from changes that might have happened anyway over the same year. Neither study reports what happens between three months and twelve months, or beyond twelve months, and the FDA clearance record itself lists no tightening indication at all, so there is no regulatory duration figure to fall back on either. Ask the clinic which of these two studies, if either, they are basing an expected duration on, and what they would check at a follow-up visit to judge whether the treatment is doing what you expected.
Sources: Study — split-face, single-blind evaluation of an infrared device (n=13, 3-month follow-up)Case series — infrared device for skin laxity (n=25, follow-up up to 12 months)FDA 510(k) K042165 (2004-10-18) — Cutera Titan, infrared lamp classification and indications for use
What should you confirm and disclose at the consultation?
Ask which claim the clinic is making for your session — pain relief, circulation, muscle relaxation or a change in skin appearance — and what that claim is based on. Ask about the device generation, the area to be treated, how many passes are planned, who performs the procedure, and what follow-up is included. Disclose implanted electronic devices, metal near the treatment area, pregnancy or breastfeeding, active skin disease or infection in the area, healing or bleeding problems, the medicines you take, and any recent aesthetic procedures in the same area. If you are visiting Korea for a short stay, share your travel dates so the clinic can plan the session around them.
When should treatment be postponed or reviewed by a doctor first?
When the treatment area has an active infection, broken or inflamed skin, or when your health history may affect the safety of a heat-based device, bleeding or healing. The source cited on this page does not publish a contraindication list for Titan, so the following are screening topics to raise with the clinician rather than a sourced list: implanted electronic devices, metal near the treatment area, pregnancy or breastfeeding, and recent aesthetic procedures in the same area. The decision belongs to the treating doctor after an in-person assessment.
Which symptoms after treatment need a call to the clinic?
This checklist is general post-procedure safety guidance, not a finding from the sources cited elsewhere on this page. Contact the clinic promptly for blistering, a suspected burn, increasing pain, drainage, spreading redness or warmth, fever, or any unexpected change in sensation over the treated area. Seek emergency help for breathing difficulty, fainting, or sudden swelling of the lips, mouth, tongue or throat.
Infrared lamp, laser, RF or HIFU: which regulatory category are you actually booking?
These are different energy categories with different regulatory records, not tiers of one treatment. The only sourced classification on this page is Titan’s own record as an infrared lamp, so use the table to line up what to confirm for each method rather than to rank them.
| Method | Energy and delivery | Regulatory category (per sources cited here) | Confirm before booking |
|---|---|---|---|
| Titan (infrared lamp) | Infrared light filtered to roughly 0.8–2.0 µm, with contact cooling | 21 CFR 890.5500, infrared lamp; FDA 510(k) K042165, product code ILY | Whether the word “tightening” or “lifting” used to describe the session matches the cleared indications, the device generation, and the number of sessions planned |
| Laser-based devices | Coherent, single-wavelength light | Regulated under separate 510(k) product codes specific to each device and its own stated indications | The exact device name, its wavelength, and the indication printed on its own FDA record |
| Radiofrequency (RF) devices | Electrical current delivered through electrodes | Regulated under product codes distinct from the infrared lamp category described here | The exact device and generation, and the indication printed on its own record |
| HIFU devices | Focused ultrasound energy | Regulated under product codes distinct from the infrared lamp category described here | The exact device name and the indication printed on its own record |
This table is a consultation map for comparing how each method is categorized and what to ask, not a ranking of results. The sources cited on this page describe Titan’s own regulatory record; they do not set Titan against laser, RF or HIFU devices directly.
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.
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.
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 Titan a laser, a radiofrequency device or an ultrasound device?
None of those — Titan uses infrared light, filtered to roughly 0.8–2.0 µm, paired with contact cooling. In the U.S., that places it in a regulatory category built for infrared lamps rather than the categories used for lasers, RF or focused-ultrasound devices.
Is Titan FDA-cleared for skin tightening?
No. The U.S. FDA 510(k) record K042165 lists Titan under 21 CFR 890.5500 as an infrared lamp, and its indications cover local heating, temporary relief of minor muscle and joint pain and stiffness, arthritis-related relief, increased local blood circulation and muscle relaxation. The word tightening is not part of that list.
What does the FDA record actually say Titan is cleared to do?
It lists local heating for the purpose of elevating tissue temperature, temporary relief of minor muscle and joint pain and stiffness, temporary relief of joint pain associated with arthritis, temporary increase in local blood circulation, and relaxation of muscles. That is the full indications list on the record cited here.
What is a 510(k) clearance, and is it the same as an approval of a specific marketing claim?
A 510(k) clearance is a determination that a device is substantially equivalent to a device already legally on the market — it is not an approval of any single marketing phrase. K042165 was decided for Titan on 2004-10-18 through that process, and the finding attaches to the device and the indications on that record, not to whichever word a clinic later chooses to advertise a session with.
Do the independent studies support calling Titan a tightening treatment?
Two independent studies on an infrared device are cited on this page, and neither one changes the wording of the FDA clearance. The split-face study reported a statistically significant difference (p=0.031) between treated and untreated sides in 13 participants, and the case series followed 25 participants with no control group; the clearance’s own indications remain about pain relief, circulation and muscle relaxation.
What did the split-face study find, and how large was it?
It found a statistically significant difference (p=0.031) between the treated side of the face and the untreated control side in a single-blind evaluation — but the study enrolled only 13 participants and followed them for three months, which makes it a small trial rather than a large confirmatory one.
What did the case-series study find, and did it include a control group?
It followed 25 participants treated with an infrared device for skin laxity for up to 12 months, and it had no control group. Without a comparison group, the changes observed in those 25 participants cannot be separated from changes that might have occurred over the same period without treatment.
Why doesn’t the existence of these studies change the cleared indications?
Because a 510(k) clearance is a fixed regulatory record tied to the filing that was reviewed and decided — for Titan, K042165, decided 2004-10-18 — and it changes only through a new FDA filing, not through later journal publications. The two studies cited here were published after that clearance and sit alongside its indications rather than editing them.
Does it hurt, and how does the cooling factor in?
The source cited on this page does not publish a pain score for Titan. What is documented is that the device pairs infrared light with contact cooling at the skin surface; ask the clinic what comfort measures they use, and tell the operator during the session if the heat is not tolerable.
Is there downtime after a Titan session?
No recovery timetable is published in the sources cited on this page. Ask the clinic what to expect after your specific session, and if you are travelling, share your departure date before booking so any follow-up fits your trip.
How many sessions are usually discussed, and how far apart?
No session count or interval is documented in the sources cited on this page — the split-face study followed participants for three months and the case series for up to 12 months, which describe observation windows rather than treatment schedules. Ask the clinic what they propose and why.
Can I have Titan with a pacemaker or another implanted electronic device?
That has to be cleared by the treating doctor before you book. The source cited on this page publishes no contraindication list for Titan, so implanted electronic devices and metal near the treatment area are standard screening topics to raise at the consultation rather than something this page can rule in or out for you.
Titan uses infrared light rather than a laser or RF — does that make it automatically low-risk?
No. The type of energy does not by itself decide the risk profile of a session. Any heat-based device carries the possibility of a burn, and temporary redness or warmth can follow a session; ask the clinic what they see in practice and how to reach them afterward.
If a clinic describes a Titan session as tightening or lifting, what should I ask?
Ask what result they mean by that word and whether it is based on the FDA clearance or on the independent studies described elsewhere on this page. The FDA record for Titan (K042165) lists local heating, temporary relief of minor muscle and joint pain and stiffness, arthritis-related relief, increased local blood circulation and muscle relaxation — not tightening or lifting — so a claim beyond that list is the clinic’s own description rather than the wording on the regulatory record.
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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