Derma-2— 510(k) K253911

Substantially Equivalent

Neko Health AB

FDA 510(k) clearance K253911 for Derma-2, Substantially Equivalent on 2026-05-20. Applicant: Neko Health AB. Device class: 1.

Clearance details

Applicant
Neko Health AB
Product code
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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Data sourced from openFDA. This site is unofficial and independent of the FDA.