510(k) K963204
K963204 is an FDA 510(k) premarket notification submitted by Aesthetic Lasers, Inc. for the device "DMS-1000C DERMOABRADER". The FDA issued a decision of Substantially Equivalent on December 9, 1996. The device falls under product code GFE (Brush, Dermabrasion, Powered), a Class I device regulated under 21 CFR 878.4820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1996
- Date Received
- August 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Dermabrasion, Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type