K253911
- 510(k) number
- K253911
- Device name
- Derma-2
- Applicant
- Neko Health AB SE
- Product code
- LHQ — System, Telethermographic (Adjunctive Use)
- Decision date
- 2026-05-20
- Date received
- 2025-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253911.pdf
Official FDA record: K253911
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.