510(k) K203788 ยท GEX Powered Laser Surgical Instrument
DermaV Laser System
| Applicant | Lutronic Corporation, Deogyang-Gu, Goyang-Si, KR |
| Decision | Substantially Equivalent, Mar 26, 2021 |
| Received | Dec 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | Lutronic Corporation Product Name: DermaV Laser System
Model/Catalog Number: DermaV
Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.