510(k) K192519 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Multi-modality workstation
| Applicant | Beijing Superlaser Technology Co., Ltd., Xihongmen Town, Daxing District, Beijing, CN |
| Decision | Substantially Equivalent, Nov 27, 2019 |
| Received | Sep 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192519
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.