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U.S. Department of Health and Human Services

Product Classification
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Device laser, comb, hair
Regulation Description Infrared lamp.
Definition Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Physical State Light emitting stimulator
Technical Method Pass laser light emitting comb across the scalp three times a week for at least 26 weeks.
Target Area Growth of scalp hairs
Regulation Medical Specialty Physical Medicine
Review Panel General & Plastic Surgery
Product CodeOAP
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 890.5500
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
Third Party Review Not Third Party Eligible
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