Brush, Dermabrasion, Powered
The Brush, Dermabrasion, Powered (product code GFE) is a motor-driven abrasive instrument used to mechanically resurface skin by removing the outer epidermal layers, commonly applied in plastic surgery for scar revision, treatment of acne scars, and cosmetic skin smoothing. It is classified as an FDA Class 1 device, the lowest risk tier, subject to general controls with no premarket notification required. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device has no special regulatory flags.
Research product code GFE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- GFE
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 153 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 153 registration numbers. Click on an entry to view related FDA registrations.