510(k) K191611 ยท GEX Powered Laser Surgical Instrument
Diode Laser Therapy Systems
| Applicant | Wingderm Electro-Optics , Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Jul 31, 2019 |
| Received | Jun 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2024 | WINGDERM ELECTRO-OPTICS LTD. Diode Laser Hair Removal model: WLA-01 Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.