DERMABRADER
FDA 510(k) clearance K905046 · decided 1990-12-19
Clearance details
- K-number
- K905046
- Device name
- DERMABRADER
- Applicant
- Aaron Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1990-11-08
- Decision date
- 1990-12-19
- Days to decision
- 41 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
- St. Petersburg, FL, 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 |
|---|---|---|
| DMS-1000C DERMOABRADER (K963204) | Aesthetic Lasers, Inc. | 1996-12-09 |
Recalls involving this device
No recalls on record reference this clearance.