The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Mcl 31 Dermablate.
| Device ID | K150140 |
| 510k Number | K150140 |
| Device Name: | MCL 31 Dermablate |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena, DE 07747 |
| Contact | Antje Katzer |
| Correspondent | Antje Katzer ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 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 | 2015-01-22 |
| Decision Date | 2015-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058784000224 | K150140 | 000 |
| 04058784000088 | K150140 | 000 |