Dermasensor, Inc.
Country not established
- Devices
- 2
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Dermasensor, Inc. makes
Dermasensor, Inc. manufactures dermatological elastic scattering spectroscopy probes, including the DermaSensor device, which analyzes skin properties through spectroscopic analysis.
The company’s products are classified as Class II medical devices and are listed in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
DermaSensor Ref DEN230008
Regimes: De Novo Registry: 510(k)
Company details
- DUNS number
- 009483550
- [email protected]
- Phone
- 1-855-373-6767
FDA recalls
FDA recall records list 1 recall initiated by Dermasensor, Inc., initiated on 2025-10-13. By recorded status: 1 ongoing. The reasons filed fall into these groups: performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 13 Oct 2025 Z-0583-2026 Class II Ongoing Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Frequently asked questions
How many devices does Dermasensor, Inc. have in the registry?
The registry currently lists 2 devices for Dermasensor, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dermasensor, Inc.'s devices?
Among its 2 most recently registered devices, Dermasensor, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Dermasensor, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dermasensor, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Dermasensor, Inc.?
FDA recall records list 1 recall initiated by Dermasensor, Inc., the most recent initiated on 2025-10-13. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Dermasensor, Inc. in the registry?
The most recently registered devices listed for Dermasensor, Inc. include DermaSensor 10101 and DermaSensor.