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Chief MD, Gangnam
Duk-ha Kim
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Ultherapy FDA filing guide: classic device vs the PRIME lineage
Ultherapy
The original Ultherapy control unit holds its own U.S. FDA 510(k) record, K180623, decided substantially equivalent on 2018-05-04 as a traditional 510(k) with predicate K134032. The filing for Ultherapy PRIME, K233996, is a special 510(k) that names the classic device (K180623) as its predicate — so on paper, the PRIME clearance is built on the record of the classic device, not the other way round. The body-area and knee indications trace only through the PRIME-era filings.
- Classic device filing
- K180623, decided 2018-05-04, traditional 510(k)
- PRIME filing
- K233996, special 510(k), predicate K180623
- Body areas added by
- K243035, decided 2025-02-24, predicate K233996
- Knee added by
- K260618, decided 2026-05-21, predicate K250418
Does the classic Ultherapy device have its own separate FDA filing?
Yes. The FDA 510(k) database lists K180623 for the Ultherapy control unit, decided substantially equivalent on 2018-05-04. That filing is a traditional 510(k), and the predicate device it compared against is K134032, an earlier Ultherapy generation. This is the record for the classic, original unit, filed years before Ultherapy PRIME existed as a separate product.
Sources: FDA 510(k) K180623 (2018-05-04) — Ultherapy, traditional 510(k), predicate K134032
What is the difference between a traditional 510(k) and a special 510(k)?
A traditional 510(k) is the standard review pathway: the manufacturer submits a full comparison between the new device and a predicate device already on the market, and the FDA reviews that comparison to decide substantial equivalence. A special 510(k) is a narrower pathway available when a manufacturer changes a device it already has cleared — the FDA relies on the design-control documentation the manufacturer already holds for that change, rather than a full new comparison. K180623, the classic device, went through the traditional pathway; K233996, PRIME, went through the special pathway, which by definition means the filing was for a change to a device already owned by the same manufacturer.
Sources: FDA 510(k) K180623 (2018-05-04) — Ultherapy, traditional 510(k), predicate K134032FDA 510(k) K233996 — Ultherapy PRIME, special 510(k), predicate K180623
Which device is named as the predicate for Ultherapy PRIME?
K233996, the filing for Ultherapy PRIME, names K180623 — the classic device — as its predicate. In 510(k) terms, that means the substantial-equivalence argument for PRIME rests on the existing record of the classic unit, not on a new argument built from scratch. So on paper, the classic filing is the foundation the PRIME filing stands on.
Sources: FDA 510(k) K233996 — Ultherapy PRIME, special 510(k), predicate K180623FDA 510(k) K180623 (2018-05-04) — Ultherapy, traditional 510(k), predicate K134032
Does a 510(k) filing mean the FDA approved the device?
No — a 510(k) is a clearance decision that a new device is substantially equivalent to a device already legally on the market, not an approval of safety or effectiveness in the way a drug approval works. Every filing referenced on this page — K180623, K233996, K243035 and K260618 — is this kind of substantial-equivalence decision. Reading "cleared" as "proven to work" misreads what the paperwork actually says.
Sources: FDA 510(k) K180623 (2018-05-04) — Ultherapy, traditional 510(k), predicate K134032FDA 510(k) K233996 — Ultherapy PRIME, special 510(k), predicate K180623
Is the face indication wording the same on the filings for both devices?
Yes. Both the classic filing and the PRIME-era filings cover the same face and neck indications: lifting the eyebrow, improving lax skin on the neck and under the chin, and improving lines and wrinkles on the décolleté. Nothing in the sources used on this page shows the face indication wording changing between the classic device and PRIME.
Sources: FDA 510(k) K180623 (2018-05-04) — Ultherapy, traditional 510(k), predicate K134032FDA 510(k) K233996 — Ultherapy PRIME, special 510(k), predicate K180623
Which filing added the abdomen and arm indications, and which device is its predicate?
K243035, decided substantially equivalent on 2025-02-24, is the filing that added skin-laxity indications for the abdomen, the anterior arms and the posterior arms. Its predicate is K233996 — Ultherapy PRIME — not the classic device. That means, strictly on paper, the body-area indication traces its lineage through PRIME, and K180623 — the filing for the classic device — does not carry these body areas.
Sources: FDA 510(k) K243035 (2025-02-24) — body areas added, predicate K233996FDA 510(k) K233996 — Ultherapy PRIME, special 510(k), predicate K180623
Which filing added the knee indication?
K260618, decided substantially equivalent on 2026-05-21, added the knee to the skin-laxity indications. That filing names K250418 as its predicate, continuing the same chain that runs through the body-area filing rather than back to the classic device. So the knee indication, like the abdomen and arm indications before it, sits on the PRIME side of the filing tree.
Sources: FDA 510(k) K260618 (2026-05-21) — knee added, predicate K250418
Why does it matter which device a body-area or knee indication traces back to?
Because the indication a control unit can lawfully claim is tied to its own 510(k) record, not to the brand name on the machine. A unit whose only filing is the classic K180623 record carries the face and neck indication, and nothing in that filing covers the abdomen, arms or knee. Those body-area and knee claims exist only because of the later PRIME-lineage filings, K243035 and K260618. Reading the filing lineage tells you what the paperwork for a specific unit actually covers.
Sources: FDA 510(k) K180623 (2018-05-04) — Ultherapy, traditional 510(k), predicate K134032FDA 510(k) K243035 (2025-02-24) — body areas added, predicate K233996FDA 510(k) K260618 (2026-05-21) — knee added, predicate K250418
Why do the FDA summaries describe the same ultrasound principle with two different phrases?
The classic filing, K180623, describes the technology as "High Intensity Focused Ultrasound (HIFU)". Starting with K233996, the FDA summary text switches to "Low-intensity, highly focused ultrasound". Both phrases describe the same underlying mechanism — focused ultrasound energy delivered to a set depth — and the sources on this page give no data showing that the later wording reflects a change in how much energy is delivered or how a treatment performs. Treat it as a documented difference in how the filing text names the technology, not as a claim that one version is stronger or weaker.
Sources: FDA 510(k) K180623 (2018-05-04) — Ultherapy, traditional 510(k), predicate K134032FDA 510(k) K233996 — Ultherapy PRIME, special 510(k), predicate K180623
What clinical evidence does the classic device filing lineage cite?
K121700, cited as clinical data for the device family, describes an open-label study of 70 subjects: 51 of the 70 showed at least 20 mm² of improvement, and blinded evaluators confirmed improvement in 84.3% of cases. This is the evidence tied to the earlier device record, separate from the pooled literature reviews cited in the PRIME-era body-area and knee filings.
Sources: FDA 510(k) K121700 — clinical data cited for the device family
What clinical evidence does the body-area filing cite?
K243035 cites a literature review of 7 studies, with between 54 and 113 subjects per treated area. That is the evidence the filing itself refers to for the abdomen and arm indications, separate from the open-label study cited for the classic device and separate from the citation in the knee filing.
Sources: FDA 510(k) K243035 (2025-02-24) — body areas added, predicate K233996
What clinical evidence does the knee filing cite?
K260618 cites a literature review of 3 studies, totaling 44 subjects, with follow-up to 180 days. That is the evidence named in the knee filing specifically — a smaller, separately cited body of literature than the one referenced in the abdomen and arm filing.
Sources: FDA 510(k) K260618 (2026-05-21) — knee added, predicate K250418
How long does the effect last?
None of these three clinical citations was designed to show how long a result lasts. The classic-device citation, K121700, is an open-label study with no untreated comparison group; the body-area filing, K243035, cites a literature review pooling 54 to 113 subjects per area without a stated follow-up window; and the knee filing, K260618, is the only one of the three with a stated follow-up — 180 days — drawn from just 3 studies and 44 subjects total. A result observed at 180 days in a small pooled sample is a different claim from a result that lasts a fixed number of months, and none of the three compares treatment against no treatment. What is more likely to decide how long a change holds is which filing lineage — and so which transducer settings — applies to the area being treated, and each person’s own tissue response. Ask the clinic which of these three citations, if any, applies to the area you are booking, and what follow-up interval they recommend.
Sources: FDA 510(k) K121700 — clinical data cited for the device familyFDA 510(k) K243035 (2025-02-24) — body areas added, predicate K233996FDA 510(k) K260618 (2026-05-21) — knee added, predicate K250418
How do you read a 510(k) summary to see what a device is actually cleared to do?
Three fields matter: the filing number and decision date, the predicate device it was compared against, and the indications-for-use statement, which is the exact wording of what the device may be marketed to do. A brand name or a control-unit label does not tell you these three things — only the filing itself does. When a clinic or a manufacturer page names a filing number, that number can be looked up directly in the FDA 510(k) database.
How do you find out which filing lineage a particular machine belongs to?
Ask the clinic for the control-unit model name printed on the machine, and ask which indications it is being used for. A face-only session and an abdomen or knee session are not automatically covered by the same filing — the record for the classic unit stops at the face and neck, while the abdomen, arm and knee indications sit on separate, later filings tied to PRIME. The model name and the treatment area together tell you which filing lineage actually applies.
What should you ask before booking, given these filing differences?
Ask which control unit is in the room, whether the area you want treated is the face and neck or a body area such as the abdomen, arm or knee, and — if it is a body area — which filing the clinic understands to cover it. Disclose pregnancy or breastfeeding, active skin infection or open or inflamed skin in the treatment area, implants or devices in or near that area, medicines affecting bleeding or healing, and recent fillers, toxins, lasers or other energy treatments, so a clinician can judge suitability and timing in person. Contact the clinic promptly if symptoms worsen instead of settling — increasing pain, blistering, spreading redness or warmth, fever, persistent numbness, new weakness or facial asymmetry.
What does the paperwork actually show for the classic device versus PRIME?
This table lists only the facts stated in the five FDA 510(k) summaries cited on this page. It is not a ranking and not a claim that one device performs better than the other.
| Filing detail | Classic Ultherapy — K180623 | Ultherapy PRIME lineage — K233996 and later |
|---|---|---|
| Own 510(k) number and decision date | K180623, decided 2018-05-04 | K233996 (special 510(k)); body areas via K243035 (2025-02-24); knee via K260618 (2026-05-21) |
| Review pathway | Traditional 510(k) | Special 510(k) for K233996 |
| Predicate device named in the filing | K134032 | K180623 for K233996; K233996 for K243035; K250418 for K260618 |
| Wording for the underlying ultrasound principle | "High Intensity Focused Ultrasound (HIFU)" | "Low-intensity, highly focused ultrasound" |
| Face and neck indications (eyebrow, submental/neck, décolleté) | Covered by K180623 | Same wording carried forward from K233996 |
| Abdomen and arm indications | Not part of this filing | Added by K243035 |
| Knee indication | Not part of this filing | Added by K260618 |
This table only reflects what the cited FDA 510(k) summaries state. It does not compare treatment outcomes or say one device is better than the other.
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.
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Frequently asked questions
Does the classic Ultherapy device have its own FDA filing separate from PRIME?
Yes — the classic control unit record is K180623, decided substantially equivalent on 2018-05-04 as a traditional 510(k) with predicate K134032. Ultherapy PRIME has its own separate filing, K233996, filed later as a special 510(k). The two are distinct FDA records, not the same paperwork under two names.
What is a traditional 510(k), in plain terms?
It is the standard 510(k) pathway, where a manufacturer submits a full comparison between a new device and an existing predicate device, and the FDA reviews that comparison to decide substantial equivalence. K180623, the classic Ultherapy filing, went through this pathway with K134032 as its predicate. It is the more thorough of the two review types referenced on this page.
What is a special 510(k), and why did Merz use one for PRIME?
A special 510(k) is a narrower pathway for a manufacturer changing a device it already has cleared, relying on design-control documentation the manufacturer already holds for the change, rather than a full new comparison. K233996, the PRIME filing, went through this pathway, which by definition treats PRIME as a change to an existing cleared device rather than an entirely new one. The predicate named in that filing is K180623, the classic device.
Does a 510(k) mean the FDA has approved the device as safe and effective?
No — a 510(k) clearance is a decision that a device is substantially equivalent to one already legally marketed, not a safety-and-effectiveness approval in the way a drug approval works. All four numbered filings on this page — K180623, K233996, K243035, K260618 — are this type of decision. "Cleared" describes the regulatory pathway, not a verdict on results.
Is the face and neck indication wording different between the classic device and PRIME?
No — the sources used on this page show the same face and neck wording on both: lifting the eyebrow, improving lax skin on the neck and under the chin, and improving décolleté lines and wrinkles. Nothing in the classic filing or the PRIME filing shows that wording changing.
Which filing covers the abdomen and arms, and does the classic device own record include them?
K243035, decided substantially equivalent on 2025-02-24, is the filing that added the abdomen, anterior arms and posterior arms. Its predicate is K233996 — Ultherapy PRIME — so K180623, the record for the classic device, does not carry these body-area indications.
Which filing added the knee, and what predicate does it name?
K260618, decided substantially equivalent on 2026-05-21, added the knee to the skin-laxity indications, and it names K250418 as its predicate. That keeps the knee indication inside the same later chain as the abdomen and arm filing, rather than tracing back to the classic device.
If the machine at a clinic only has the classic filing, can it still be used for the abdomen or knee?
The classic filing, K180623, is a face-and-neck record and does not include the abdomen, arm or knee indications added later by K243035 and K260618. Whether a specific control unit at a specific clinic covers those areas is a question about which filing lineage the record for that unit belongs to, which is why asking for the model name and the relevant filing number matters.
Why does one FDA summary say HIFU and another say low-intensity, highly focused ultrasound for what sounds like the same treatment?
K180623 uses the phrase "High Intensity Focused Ultrasound (HIFU)", and K233996 onward uses "Low-intensity, highly focused ultrasound". Both describe the same underlying mechanism of focused ultrasound delivered to a set depth, and the sources on this page do not show this wording change reflecting a difference in energy delivered or in results.
What clinical data is cited in the classic device filing lineage?
K121700 describes an open-label study of 70 subjects, in which 51 of the 70 showed at least 20 mm² of improvement and blinded evaluators confirmed improvement in 84.3% of cases. This is separate from the literature reviews cited in the later body-area and knee filings.
What clinical evidence backs the abdomen and arm filing?
K243035 cites a literature review of 7 studies, with 54 to 113 subjects per treated area. That is the evidence the filing itself names for the body-area indications, distinct from the open-label study cited for the classic device.
What clinical evidence backs the knee filing?
K260618 cites a literature review of 3 studies, totaling 44 subjects, with follow-up to 180 days. It is a smaller, separately cited body of literature from the one referenced in the abdomen and arm filing.
How do I check what a specific control unit is actually cleared to do?
Look at three fields in its 510(k) record: the filing number and decision date, the predicate device named, and the exact indications-for-use wording. Those three fields — not the brand name printed on the machine — define what a specific unit can lawfully be marketed to treat.
What should I ask a clinic before booking, given these separate filings?
Ask which control unit is in the room and confirm whether your treatment area — face and neck, or a body area such as abdomen, arm or knee — matches a filing that covers it. Also disclose pregnancy or breastfeeding, active skin infection or open or inflamed skin in the area, nearby implants or devices, medicines affecting bleeding or healing, and any recent energy-based or injectable treatments, so a clinician can judge suitability in person.
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