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U.S. Department of Health and Human Services

Product Classification
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Device light based over-the-counter hair removal
Regulation Description Laser 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.
Physical State Use of thermal energy
Technical Method Use of thermal energy to kill hair follicles for hair removal
Target Area The device generally targets skin (including dermis, epidermis), underlying soft tissue and hair follicles.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOHT
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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