510(k) K003614 ยท GEX Powered Laser Surgical Instrument
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
| Applicant | Coherent Star, Pleasanton CA, US |
| Decision | Substantially Equivalent, Mar 13, 2001 |
| Received | Nov 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003614
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2015 | Lumenis Limited Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Terminated |
GEX | None listed |
| Feb 23, 2006 | Lumenis Inc. Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers;
Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.