510(k) K192350 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Medical Non-Ablative Fractional Laser Systems
| Applicant | Wingderm Electro-Optics , Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Apr 30, 2020 |
| Received | Aug 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192350
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2024 | WINGDERM ELECTRO-OPTICS LTD. Non-ablative Fractional Laser Systems, Model: WFB-01 Open, Classified |
ONG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.