DMS-1000C DERMOABRADER
FDA 510(k) clearance K963204 · decided 1996-12-09
Clearance details
- K-number
- K963204
- Device name
- DMS-1000C DERMOABRADER
- Applicant
- Aesthetic Lasers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-15
- Decision date
- 1996-12-09
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- GFE
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Annapolis, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DERMABRADER (K905046) | Aaron Medical Industries | 1990-12-19 |
Recalls involving this device
No recalls on record reference this clearance.