510(k) K010284 ยท GEX Powered Laser Surgical Instrument
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
| Applicant | Laserscope, San Jose CA, US |
| Decision | Substantially Equivalent, May 1, 2001 |
| Received | Jan 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010284
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2011 | AMS Innovative Center - San Jose AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230;
Product is manufactured and distributed by AMS Solutions,
San Jose, CA
The GreenLight Surgical Laser System and accessories are intended for Terminated |
GEX | None listed |
| Mar 20, 2008 | AMS Innovative Center - San Jose GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134. Terminated |
GEX | None listed |
| Feb 26, 2008 | AMS Innovative Center - San Jose American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San J Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.