IOB
6 FDA 510(k) clearances · Product code
57 daysmedian time to decision
341 days90th percentile
6clearances measured
FDA profile
- Official device name
- Lamp, Infrared, Non Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1
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 |
|---|---|---|
| DERMALIGHT PSORACOMB (K903660) | Solitec GmbH | 1991-07-17 |
| ULTRALITE PANELITE (K910091) | Ultralite | 1991-05-30 |
| SUNMASTER (K842276) | Mt. Hood Mfr., Inc. | 1984-07-16 |
| UVA FLUORESCENT TANNING LAMPS (K813451) | North American Philips Corp. | 1982-01-28 |
| OSRAM UVA LAMP (K812853) | Osram GmbH | 1981-12-09 |
| SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 (K760519) | Dermatron Corp. | 1976-09-03 |
Track IOB automatically
Every clearance here is in the API, with alerts when new ones post.