FDA-Device2025-12-03Class IIPROCESSING DEFECT
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
Hazard
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Intended for
Adults
Illnesses reported
None reported
Sold states
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Affected count
343 (9 units affected)
Manufactured in
801 Brickell Ave Ste 1610, N/A, Miami, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0583-2026Want us to check the next one for you?
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