The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Dermav Laser System.
| Device ID | K203788 |
| 510k Number | K203788 |
| Device Name: | DermaV Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lutronic Corporation Lutronic Center, 219, Sowon-Ro Deogyang-gu, Goyang-si, KR 410220 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir Lutronic Corporation Lutronic Center, 219, Sowon-Ro Deogyang-gu, Goyang-si, KR 410220 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-03-26 |