510(k) K092735 ยท GEX Powered Laser Surgical Instrument
GREENLIGHT XPS LASER SYSTEM
| Applicant | American Medical Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 9, 2009 |
| Received | Sep 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092735
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2013 | AMS Innovative Center - San Jose GreenLight HPS (High Performance System)
GreenLight XPS (Xcelerated Performance System)
Manufactured by AMS, Solutions for Life
Innovation Center.
GreenLight HPS and XPS Surgical Lasers Systems and Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.