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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 Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.5400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use
Third Party Review Not Third Party Eligible
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