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U.S. Department of Health and Human Services

Radiation Emitting Electronic Product Codes
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Productlight based over-the-counter hair removal
Regulation DescriptionLaser surgical instrument for use in general and plastic surgery and in dermatology.
Definition
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Product Description General & Plastic Surgery Medical Laser Products
Product CodeOHT
Radiation Type Optical
Radiation Safety Report Type Required? Product
Annual Reports Required? Yes
Regulation Number 878.4810
Applicable Performance Standard(s) Laser products. [1040.10]
Specific purpose laser products. [1040.11]
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