510(k) K153727 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
INTRAcel Premium Fractional RF Micro Needle (FRM) System
| Applicant | Jeisys Medical, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Jul 21, 2016 |
| Received | Dec 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153727
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.