510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230008Unknown

DermaSensor

Dermasensor Inc, Miami FL / Direct, Unknown
FDA source (opens on fda.gov)

DEN230008 is the FDA 510(k) clearance record for DermaSensor, a class II device, cleared for Dermasensor, Inc. on under FDA product code QZS (Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer). FDA's definition for product code QZS reads: "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...". FDA records list one 510(k) clearance for Dermasensor, Inc. As of , FDA records show no recalls naming DEN230008.

Clearance record

Decision date
Received
(344 days to decision)
Product code
QZS Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
Regulation
21 CFR 878.1830
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Dermasensor, Inc. 80 SW 8th St. #2000, Miami FL
Third party review
No

Clearances, product code QZS

Trailing 12 months

FDA records hold no clearances under product code QZS in the trailing twelve months.

FDA records show no clearances under product code QZS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QZS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260