Brush, Dermabrasion, Manual
The Brush, Dermabrasion, Manual (product code GED) is a manually operated abrasive brush used in dermabrasion procedures to mechanically remove the outer layers of skin, typically employed in plastic surgery for scar revision, treatment of superficial skin irregularities, or cosmetic resurfacing. It is classified as FDA Class 1, the lowest risk level, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GED
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- 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 53 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 53 registration numbers. Click on an entry to view related FDA registrations.