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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
De Novo Number DEN230008
Device Name DermaSensor
Requester
dermasensor inc.
80 sw 8th street #2000
miami,  FL  33130
Contact cody simmons
Regulation Number878.1830
Classification Product Code
QZS  
Date Received02/02/2023
Decision Date 01/12/2024
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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