510(k) K142860 ยท GEX Powered Laser Surgical Instrument
Lumenis M22 System
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Jan 21, 2015 |
| Received | Oct 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142860
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2016 | Lumenis Ltd Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.