FDA product code PKT

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

General, Plastic Surgery·Class 2·21 CFR 878.5400
US regulatory classifications
US Product Code (FDA)
PKT
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.5400
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
Yes
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

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About this record

Laser For Disruption Of Adipocyte Cells For Aesthetic Use is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.