FSW
8 FDA 510(k) clearances · Product code
81 daysmedian time to decision
110 days90th percentile
8clearances measured
FDA profile
- Official device name
- Light, Surgical, Endoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 1 · 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 |
|---|---|---|
| RADLITE TISSUE RETRACTOR SYSTEM (K022989) | Genzyme Biosurgery | 2002-11-25 |
| XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (K013511) | Aculux, Inc. | 2002-02-01 |
| MEDICAM XENON LIGHT SOURCE (K943342) | M.P. Video, Inc. | 1994-10-17 |
| CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (K934337) | Cuda Products Co. | 1993-11-18 |
| ILLUMINATOR IV MINOR SURGERY LIGHT (K922279) | Medical Illumination, Inc. | 1992-09-02 |
| LM-300TWIN (K913135) | Leisegang Medical, Inc. | 1991-09-18 |
| MEDICAL DYNAMICS LIGHT SOURCE (K894319) | Medical Dynamics, Inc. | 1989-10-03 |
| ULTRA-LUX LIGHT SOURCE (K870898) | Medline Industries, Inc. | 1987-03-18 |
Track FSW automatically
Every clearance here is in the API, with alerts when new ones post.