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DERMASENSOR INC: DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on l

Medical DevicesSource: FDA (device) · Date: 2025-12-03

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
DERMASENSOR INC
Product
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Reason / hazard
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Classification
Class II
Status
Ongoing
Distribution / sold at
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Recall initiated
2025-10-13
Code info
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Product quantity
343 (9 units affected)
Voluntary mandated
Voluntary: Firm initiated
City
Miami
State
FL
Country
United States
Event id
97780
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