FDA product code FTC: Light, Ultraviolet, Dermatological
FTC is the FDA product code for light, ultraviolet, dermatological. It is a Class II device, regulated under 21 CFR 878.4630 and reviewed by the General and Plastic Surgery panel. FDA has cleared 272 510(k) submissions under FTC, 11 in the last five years, from 150 different applicants. The average 510(k) review took 77 days (median 43); 93 days on average over the last three years. FDA has posted 11 recalls for FTC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Light, Ultraviolet, Dermatological |
| Device class | Class II |
| Regulation | 21 CFR 878.4630 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FTC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 111 |
| 2018 | 3 | 177 |
| 2019 | 2 | 210 |
| 2020 | 5 | 220 |
| 2021 | 3 | 172 |
| 2022 | 1 | 30 |
| 2023 | 4 | 50 |
| 2024 | 1 | 86 |
| 2025 | 3 | 87 |
| 2026 | 2 | 106 |
Compare with all 510(k) review times · Search every FTC clearance
Top FTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National Biological Corp. | 26 | 2007-05-22 |
| Daavlin Distributing Co. | 14 | 2023-12-13 |
| Philips Int'L B.V. | 9 | 1985-06-27 |
| Light Sources, Inc. | 8 | 1990-04-26 |
| Mottek Intl. Corp. | 8 | 1986-02-18 |
145 more applicants have FTC clearances. See the full list in Caduvo.
Most recent FTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254234 | Choyang Medics Co., Ltd. | Phototherapy System (DUV-COMBO) | 2026-05-01 | 123 |
| K253871 | Radcliffe Watts, LLC | Klär Lite (RCW-KL1000) | 2026-03-04 | 90 |
| K250425 | APK Technology Co., Ltd. | Ultraviolet Phototherapy Device | 2025-04-07 | 52 |
| K244022 | Boston Aesthetics, Inc. | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | 2025-03-13 | 76 |
| K242977 | Xuzhou Kernel Medical Equipment Co., Ltd. | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | 2025-02-06 | 133 |
Recalls for FTC devices
11 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-04-26.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code FTC?
FTC is the FDA product code for light, ultraviolet, dermatological. It is a Class II device, regulated under 21 CFR 878.4630 and reviewed by the General and Plastic Surgery panel.
What device class is FTC?
Class II, regulation 21 CFR 878.4630. Typical premarket route: 510(k).
How long does a 510(k) take for product code FTC?
Across 272 cleared submissions the average was 77 days from receipt to decision (median 43).
Which companies have the most FTC clearances?
National Biological Corp. (26); Daavlin Distributing Co. (14); Philips Int'L B.V. (9); Light Sources, Inc. (8); Mottek Intl. Corp. (8).
Have FTC devices been recalled?
Yes: 11 product recalls across 6 recall events; the most recent began 2022-04-26.
Next steps
- Run an FDA pathway report with predicate devices for product code FTC
- Run a recall and safety report across every FTC manufacturer
- Watch product code FTC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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