FDA product code GFE: Brush, Dermabrasion, Powered
GFE is the FDA product code for brush, dermabrasion, powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under GFE, from 2 different applicants. The average 510(k) review took 78 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Brush, Dermabrasion, Powered |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GFE clearance
Top GFE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aesthetic Lasers, Inc. | 1 | 1996-12-09 |
| Aaron Medical Industries | 1 | 1990-12-19 |
Most recent GFE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963204 | Aesthetic Lasers, Inc. | DMS-1000C DERMOABRADER | 1996-12-09 | 116 |
| K905046 | Aaron Medical Industries | DERMABRADER | 1990-12-19 | 41 |
Recalls for GFE devices
openFDA lists no recalls for product code GFE.
Frequently asked questions
What is FDA product code GFE?
GFE is the FDA product code for brush, dermabrasion, powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is GFE?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFE?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most GFE clearances?
Aesthetic Lasers, Inc. (1); Aaron Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GFE
- Run a recall and safety report across every GFE manufacturer
- Watch product code GFE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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