KGL
8 FDA 510(k) clearances · Product code
59 daysmedian time to decision
120 days90th percentile
8clearances measured
FDA profile
- Official device name
- Cabinet, Phototherapy (Puva)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 3 · 2001: 7 · 2002: 4 · 2003: 4 · 2004: 2 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WALDMANN F85/100W PUVA (K852575) | Sylvania Lighting Products | 1985-08-16 |
| UV 8001K, PUVA 800, PUVA 180/200 1000 (K841795) | Waldmann Lighting Co. | 1984-08-30 |
| SPECTRA 305/350 (K820280) | Ultralite | 1982-03-05 |
| HO-B-LITE VI UNIT (K810668) | National Biological Corp. | 1981-04-23 |
| PHOTOTHERAPY LIGHT CHAMBER (K810358) | Paul B. Elder Co. | 1981-03-20 |
| PSORALITE MARK I (K791977) | Paul B. Elder Co. | 1979-12-28 |
| PSORALITE SERIES 30,000 (K791116) | Paul B. Elder Co. | 1979-09-04 |
| UVA PHOTOTHERAPY SYSTEM (K761094) | Dermatron Corp. | 1976-12-02 |
Track KGL automatically
Every clearance here is in the API, with alerts when new ones post.