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

Miami, FL, US

DERMASENSOR INC appears in FDA device records in Miami, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Dermasensor Inc in 2024.

Clearances by year, as a table
510(k) clearance decisions for Dermasensor Inc, by decision year
YearClearances
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
DEN230008DermaSensorQZSUnknown

Registered establishments

FDA registered establishments for Dermasensor Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30172541143017254114DERMASENSOR INC801 Brickell Ave Ste 1610, Miami, FL 33131 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0583-2026DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancerPotential for device to not meet specifications resulting in incorrect results or delay of referral for patients.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain