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U.S. Department of Health and Human Services

Product Classification
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Device optical diagnostic device for melanoma detection
Definition Intended in the detection of melanoma and high grade lesions among atypical lesions in order to rule-out melanoma.
Physical State Optical radiation.
Technical Method Use of visible and infrared optical radiation to generate images of targeted atypical lesions.
Target Area Atypical pigmented lesions
Review Panel General & Plastic Surgery
Product CodeOYD
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type PMA
Device Class 3
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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