510(k) K062719 ยท GEX Powered Laser Surgical Instrument
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
| Applicant | Laserscope, San Jose CA, US |
| Decision | Substantially Equivalent, Dec 1, 2006 |
| Received | Sep 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2022 | Boston Scientific Corporation GreenLight HPSEA Laser Fibers, UPN 0010-2092 Open, Classified |
GEX | None listed |
| 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 |
| Sep 25, 2010 | AMS Innovative Center - San Jose GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079 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.