Pure Global AI
FDA product code OYD

Optical Diagnostic Device For Melanoma Detection

UnknownClass 321 CFR
Verified
US regulatory classifications
US Product Code (FDA)
OYD
View Product Code Classification
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
View CFR Regulation
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Intended in the detection of melanoma and high grade lesions among atypical lesions in order to rule-out melanoma.

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01Melanoma detection02Skin cancer03Optical imaging04Diagnostic device05Dermatoscopy06Skin analysis07Lesion detection08Dermatological device09Cancer screening10Optical diagnostic
About this record

Optical Diagnostic Device For Melanoma Detection is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.