LLW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Laser, Neodymium:Yag For Gynecologic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4550
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 2 · 1995: 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 |
|---|---|---|
| DISPOSABLE LARYNGOSCOPE (K850437) | Vital Signs, Inc. | 1985-02-14 |
Track LLW automatically
Every clearance here is in the API, with alerts when new ones post.