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U.S. Department of Health and Human Services

Product Classification

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Device powered surgical instrument for improvement in the appearance of cellulite
Definition Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Physical State The device consists of a cutting blade powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.
Technical Method The device temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples.
Target Area Area with Cellulite, Fibrous Septae, Fat, Soft Tissue.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOUP
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4790
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible