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U.S. Department of Health and Human Services

Product Classification
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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.).
Physical State Laser device outputting energy at different wavelengths
Technical Method Laser energy delivered to the target area by scanning
Target Area Toe nail of the patients with onychomycosis
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePDZ
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
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
Third Party Review Not Third Party Eligible
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