The following data is part of a premarket notification filed by Aesthetic Lasers, Inc. with the FDA for Dms-1000c Dermoabrader.
| Device ID | K963204 |
| 510k Number | K963204 |
| Device Name: | DMS-1000C DERMOABRADER |
| Classification | Brush, Dermabrasion, Powered |
| Applicant | AESTHETIC LASERS, INC. 528 COLLEGE PKWY., SUITE C-1 Annapolis, MD 21401 |
| Contact | Fred De Jacma |
| Correspondent | Fred De Jacma AESTHETIC LASERS, INC. 528 COLLEGE PKWY., SUITE C-1 Annapolis, MD 21401 |
| Product Code | GFE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1996-12-09 |