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U.S. Department of Health and Human Services

Product Classification

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Device laser assisted lipolysis
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Intended to be used for laser assisted lipolysis.
Physical State The device is a laser module.
Technical Method Laser Assisted Lipolysis is a procedure that uses laser energy to melt small volume of fat. The fat is then removed from the body by aspiration.
Target Area A small volume (up to 120cc) of localized deposits of fat per treatment such as chin or upper arm (triceps)
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeORK
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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