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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 Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 890.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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