510(k) K101006 ยท GEX Powered Laser Surgical Instrument
WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
| Applicant | Alcon Research, Ltd., Fort Worth TX, US |
| Decision | Substantially Equivalent, Oct 21, 2010 |
| Received | Apr 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2011 | Wavelight AG WaveLight FS200 Femtosecond Laser System
Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2.
The WaveLight FS 200 Laser System is an ophthalmic surgi Terminated |
HNO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.