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U.S. Department of Health and Human Services

Product Classification

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Device fat reducing low level laser
Regulation Description Low level laser system for aesthetic use
Definition Non-invasive reduction in fat layer for body contouring
Physical State laser system that emits laser energy in the red spectrum
Technical Method use of low level laser energy to create pores in adipocyte cells to release lipoproteins
Target Area adipocyte cells within the fat layer of the body, this could include wasit, thighs, abdomin, hips, etc...
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOLI
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.5400
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
Recognized Consensus Standards
Third Party Review
Accredited Persons