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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lasers for temporary increase of clear nail in patients with onychomycosis
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
Product CodePDZ
Regulation Number 878.4810
Device Class 2


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