Product code FTC: 510(k) clearances and predicates
Product code FTC covers Phototherapy System (DUV-COMBO). FDA lists 272 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
272 clearances on file under product code FTC. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 so far | 2 |
Recent clearances
Newest FTC clearances in the FDA index, with applicant and decision date:
- K254234, Phototherapy System (DUV-COMBO), applicant Choyang Medics Co., Ltd., decided 2026-05-01. FDA record
- K253871, Klär Lite (RCW-KL1000), applicant Radcliffe Watts, LLC, decided 2026-03-04. FDA record
- K250425, Ultraviolet Phototherapy Device, applicant APK Technology Co., Ltd., decided 2025-04-07. FDA record
- K244022, 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z), applicant Boston Aesthetics, Inc., decided 2025-03-13. FDA record
- K242977, 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K), applicant Xuzhou Kernel Medical Equipment Co., Ltd., decided 2025-02-06. FDA record
- K242908, UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG), applicant Shanghai Sigma High-Tech Co., Ltd., decided 2024-12-19. FDA record
- K233811, DT Controlled Phototherapy Equipment, applicant Daavlin Distributing Co., decided 2023-12-13. FDA record
- K223882, Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02), applicant Shenzhen Honpal Optoelectronic Technology Co., Ltd., decided 2023-03-27. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Klär Lite (RCW-KL1000), Ultraviolet Phototherapy Device. Watch new FTC clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FTC?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FTC clearances include Phototherapy System (DUV-COMBO).
How many 510(k) clearances use product code FTC?
272 at the time this page was generated, from openFDA records.
How do I find a predicate device under FTC?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FTC clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.