Derma-2— 510(k) K253911
Substantially EquivalentNeko Health AB
FDA 510(k) clearance K253911 for Derma-2, Substantially Equivalent on 2026-05-20. Applicant: Neko Health AB. Device class: 1.
Summary
Neko Health's Derma-2 is filed under LHQ, telethermographic systems (adjunctive use). The record doesn't describe it beyond its name and that code name.
Class I, 21 CFR 884.2980. The Radiology review panel handled it as a Traditional 510(k), though the record lists Obstetrics/Gynecology as the classification panel.
Neko Health filed from Danderyd, Sweden. Review took 163 calendar days (December 8, 2025 to May 20, 2026).
Clearance details
- Applicant
- Neko Health AB
- Product code
- Product code LHQ
- Device class
- Class 1
- Regulation
- 21 CFR 884.2980
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danderyd, SE
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