Data / Medical devices / United States / Dermasensor Inc
Dermasensor Inc: FDA-registered device maker in Miami, FL, United States, 1 510(k) clearance
Dermasensor Inc is registered with the FDA (registration 3017254114) in Miami, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 12, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017254114
- Address
- 801 Brickell Ave Ste 1610, Miami, FL, United States, 33131
- Owner or operator
- DermaSensor Inc (10090725)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 22, 2024
- Registered through
- 2026
- Brand names listed
- DermaSensor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer | QZS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 12, 2024 | DEN230008 | DermaSensor | QZS | Unknown | Dermasensor, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 13, 2025 | 97780 | Class II | Ongoing | 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 | Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients. | accessdata.fda.gov |
Updated November 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.