510(k) K200971 ยท FTC Light, Ultraviolet, Dermatological
308nm Excimer System
| Applicant | Xuzhou Kernel Medical Equipment Co., Ltd., Xuzhou, CN |
| Decision | Substantially Equivalent, Dec 15, 2020 |
| Received | Apr 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200971
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.