510(k) K202250 ยท GEX Powered Laser Surgical Instrument
Dermatological Carbon Dioxide Laser Systems
| Applicant | Zhuolu Jontelaser Manufacturing Technology Co., Ltd., Zhangjiakou, CN |
| Decision | Substantially Equivalent, Nov 25, 2020 |
| Received | Aug 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202250
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.