FDA 510(k)

Derma-2

K-Number: K253911 · 2026-05-20

Decision Date2026-05-20

Product CodeLHQ

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Derma-2 is the device name listed in this FDA 510(k) record. The listed applicant is Neko Health AB. It received FDA 510(k) clearance on 2026-05-20 under 510(k) number K253911. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Derma-2?

Derma-2 is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is Neko Health AB. The 510(k) number is K253911.

When did Derma-2 receive FDA 510(k) clearance?

Derma-2 received FDA 510(k) clearance on 2026-05-20, under 510(k) number K253911.

Who is the listed applicant for Derma-2?

The FDA 510(k) record lists Neko Health AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Derma-2?

The FDA product code for Derma-2 is LHQ.

Other records listing Neko Health AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254129Spectrum-2

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.