510(k) K170121 ยท GEX Powered Laser Surgical Instrument
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, May 22, 2017 |
| Received | Jan 13, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170121
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2025 | LUMENIS, LTD. (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System;
(2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and
(3) Lumenis Pulse 120H, REF GA-0008700, Laser System. Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.