Devices · DermaSensor Inc.

DermaSensor

DermaSensor Inc. is listed for DermaSensor (DEN230008). The FDA list gives January 12, 2024 as the date of the final decision. The lead panel is General and Plastic Surgery, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QZS as “Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer”: A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230008

Official FDA database record

Date of final decision

January 12, 2024

Company on the FDA list

DermaSensor Inc.

Lead panel

General and Plastic Surgery

Primary product code

QZS

openFDA device name for the code

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Device class

2

Regulation number

878.1830

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned