Brush, Dermabrasion, Powered

Device Code: 5660

Product Code(s): GFE

Device Classification Information

Device Type ID5660
Device NameBrush, Dermabrasion, Powered
Regulation DescriptionSurgical Instrument Motors And Accessories/attachments.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4820 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGFE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5660
DeviceBrush, Dermabrasion, Powered
Product CodeGFE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSurgical Instrument Motors And Accessories/attachments.
CFR Regulation Number878.4820 [🔎]
TPLC Last Update: 2019-04-02 21:10:24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.