The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Mcl 31 Dermablate System.
| Device ID | K210634 |
| 510k Number | K210634 |
| Device Name: | MCL 31 Dermablate System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Asclepion Laser Technologies GmbH Bruesseler Strasse 10 Jena, DE 07747 |
| Contact | Dania Di Pietro Paolo |
| Correspondent | Tom Gruender Asclepion Laser Technologies Gmbh Bruesseler Strasse 10 Jena, DE 07747 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-03 |
| Decision Date | 2022-04-13 |