510(k) K253859 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Scarlet Pro (Scarlet Pro)
| Applicant | VIOL Co., Ltd., Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, Aug 27, 2026 |
| Received | Dec 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253859
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.