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U.S. Department of Health and Human Services

Product Classification

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Device dermal cooling pack/vacuum/massager
Regulation Description Contact cooling system for aesthetic use.
Definition The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.
Physical State the device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.
Technical Method release of fat and lipids from adipocyte cells resulting in reduction in fat layer
Target Area areasof the body for which a subject wishes to have reduction in size such as abdomen, thighs, waist, hips.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOOK
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use
Third Party Review Not Third Party Eligible
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