FDA 510(k)

LUNA 3D

K-Number: K253004 · 2026-06-04

Decision Date2026-06-04

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LUNA 3D is the device name listed in this FDA 510(k) record. The listed applicant is Lap GmbH Laser Applikationen. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253004. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNA 3D?

LUNA 3D is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Lap GmbH Laser Applikationen. The 510(k) number is K253004.

When did LUNA 3D receive FDA 510(k) clearance?

LUNA 3D received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253004.

Who is the listed applicant for LUNA 3D?

The FDA 510(k) record lists Lap GmbH Laser Applikationen as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUNA 3D?

The FDA product code for LUNA 3D is IYE.

Other records listing Lap GmbH Laser Applikationen 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.

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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.