FDA product code · General, Plastic Surgery
FTCLight, Ultraviolet, Dermatological
Product code FTC covers Light, Ultraviolet, Dermatological, a Class II device regulated under 21 CFR 878.4630. FDA has cleared 272 devices in this code, 2 of them in the last 12 months. Median review time across the 272 most recent decisions is 43 days. openFDA lists 15 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4630
- Review panel
- General, Plastic Surgery
- Clearances
- 272
What is happening in FTC right now?
FTC (Light, Ultraviolet, Dermatological) has three findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2742-2026, Z-2743-2026, Z-2744-2026, Z-2295-2026). 2 first-time filers in the last 12 months, Choyang Medics Co., Ltd. and Radcliffe Watts, LLC (K254234, K253871). The code is crowded, scoring 75 of 100 — 143 companies hold a clearance here and 2 arrived in the last 12 months (FTC:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2742-2026, Z-2743-2026, Z-2744-2026, Z-2295-2026 |
| New entrant | Worth knowing | K254234, K253871 |
| Crowding | Context | FTC:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in FTC?
FDA has cleared 272 devices under product code FTC since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | |
| K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | |
| K250425 | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | |
| 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) | Boston Aesthetics, Inc. | |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co., Ltd. | |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. | |
| K233811 | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | |
| K230382 | 3 Series NeoLux | Daavlin Distributing Co. | |
| K230076 | Enhanced AURORA Medical Diode System, and related accessories | Psoria-Shield, Inc. |
How long does FDA review take for FTC?
The median FDA review time for FTC is 43 days, measured across the 272 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FTC?
openFDA lists 15 recall records against product code FTC. A recall record covers one firm's corrective action and may span many device lots.
Z-2742-2026Open, ClassifiedDaavlin Distributing Company
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Z-2743-2026Open, ClassifiedDaavlin Distributing Company
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Z-2744-2026Open, ClassifiedDaavlin Distributing Company
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Z-2295-2026Open, ClassifiedDaavlin Distributing Company
Some of the Calibration/Output Certificates had the outputs reversed.
Z-1073-2022Open, ClassifiedDaavlin Distributing Company
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
Showing the 5 most recently initiated of 15. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FTC?
MAUDE holds 21 adverse-event reports naming product code FTC, 7 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FTC unusual?
FTC does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
16 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered FTC in the last year?
2 companies filed in FTC for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Choyang Medics Co., Ltd. | K254234 | |
| Radcliffe Watts, LLC | K253871 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in FTC?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FTC?
Across the 272 most recent decisions, these applicants filed most often in FTC.
| Applicant | Recent clearances |
|---|---|
| National Biological Corp. | 26 |
| Daavlin Distributing Co. | 14 |
| Philips Int'L B.V. | 9 |
| Light Sources, Inc. | 8 |
| Mottek Intl. Corp. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in FTC file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| National Biological Corp | 27 | 2 |
| Daavlin Distributing Company | 16 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch FTC
Get an email the morning anything changes in FTC — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.