FDA product code OOK

Dermal Cooling Pack/Vacuum/Massager

General, Plastic Surgery·Class 2·21 CFR 878.4340
US regulatory classifications
US Product Code (FDA)
OOK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4340
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

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About this record

Dermal Cooling Pack/Vacuum/Massager 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.