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U.S. Department of Health and Human Services

Radiation Emitting Electronic Product Codes
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Productfat reducing low level laser
Regulation DescriptionLow level laser system for aesthetic use
Definition
Non-invasive reduction in fat layer for body contouring
Product Description General & Plastic Surgery Medical Laser Products
Product CodeOLI
Radiation Type Optical
Radiation Safety Report Type Required? Product
Annual Reports Required? Yes
Regulation Number 878.5400
Applicable Performance Standard(s) Laser products. [1040.10]
Specific purpose laser products. [1040.11]

Guidance Document
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