510(k) K130164 ยท GEX Powered Laser Surgical Instrument
FIBERLASE ENDURE CO2 FIBER
| Applicant | Lumenis, Ltd., Binyamina, IL |
| Decision | Substantially Equivalent, Mar 24, 2013 |
| Received | Jan 23, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2025 | LUMENIS, LTD. OtoLase Starter Kit;
UPN: AC-2003748.
Indicated for a
variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue. Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.