510(k) K030342 ยท GEX Powered Laser Surgical Instrument
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
| Applicant | Lumenis, Ltd., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 17, 2003 |
| Received | Feb 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2006 | Lumenis Inc. Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.