510(k) K213484 ยท GEX Powered Laser Surgical Instrument
SmoothCool HR System
| Applicant | Jeisys Medical, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Apr 20, 2022 |
| Received | Oct 29, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213484
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.