Dermasensor, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Dermasensor, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QZS | Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230008 | De Novo | Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer | 2024-01-12 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-10-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Dermasensor, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06666790: DermaSensor Postmarket Surveillance Study (Recruiting, started 2024-10-08)
- NCT06690086: DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer (Completed, started 2020-08-17)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dermasensor, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Dermasensor, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Dermasensor, Inc.?
The most frequent FDA product codes under this applicant name are QZS (Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer, 1).
Next steps
- See all 0 Dermasensor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QZS, Dermasensor, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.