510(k) K011703 ยท GEX Powered Laser Surgical Instrument
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
| Applicant | Lumenis, Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 29, 2001 |
| Received | Jun 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011703
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2008 | Lumenis, Inc. Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL. Terminated |
GEX | None listed |
| Oct 12, 2006 | Lumenis Inc. Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue.
Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.