Product Code: GED FDA class 1 21 CFR 878.4800

Brush, Dermabrasion, Manual

General, Plastic Surgery

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.

510(k)s
2
FEI Numbers
53
Registration Numbers
53
Unique Applicants
2
Years Active
1

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K830259 PROTET SOAP & WASH MITT
K821801 NORSEN DEBRIDER

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.