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U.S. Department of Health and Human Services

Product Classification

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Device laser, cellulite appearance
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition For the removal of fat through laser lipolysis.
Physical State Laser system using fiber optic delivery system to deliver the laser energy to the site through a cannula
Technical Method delivery of laser energy via a cannula into the subdermal area to dissolove fat and disrupt the septae that affect the appearance of cellulite
Target Area area that have cellulite issues
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOYW
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 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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