De Novo DEN230008

Device: DermaSensor
Contact: cody simmons
De Novo number: DEN230008
Product code: QZS
Regulation: 878.1830
Classification name: software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Decision: granted (DENG)
Decision date: 2024-01-12
Date received: 2023-02-02
Classification advisory: General & Plastic Surgery
Review advisory: General & Plastic Surgery
Type: Direct

Current FDA Classification#

Product code: QZS
Device name: Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation: 878.1830
Implant: N
Life sustain/support: N