LXS
6 FDA 510(k) clearances · Product code
80 daysmedian time to decision
252 days90th percentile
6clearances measured
FDA profile
- Official device name
- Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4392
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2000: 8 · 2001: 4 · 2002: 2 · 2006: 4 · 2007: 3 · 2015: 18
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 |
|---|---|---|
| MICRORUPTER V (K023045) | Meridian AG | 2002-09-26 |
| PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. (K901605) | Phoenix Laser Systems, Inc. | 1990-12-13 |
| MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP (K895864) | Lasag AG | 1989-12-29 |
| NIDEK MODEL YC-1200 (K893987) | Nidek, Inc. | 1989-08-18 |
| NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS (K892204) | Nidek, Inc. | 1989-06-22 |
| ISL QC 2000 (K892058) | Intelligent Surgical Lasers, Inc. | 1989-06-15 |
Track LXS automatically
Every clearance here is in the API, with alerts when new ones post.