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FDA 510(k)

LUNA 3D

K-Number: K232031 · 2024-03-29

ApplicantLap GmbH Laser Applikationen
Decision Date2024-03-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUNA 3D is a medical device manufactured by Lap GmbH Laser Applikationen. It received FDA 510(k) clearance on 2024-03-29 under approval number K232031. 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 2024-03-29. It is manufactured by Lap GmbH Laser Applikationen. The 510(k) number is K232031.

When was LUNA 3D approved by the FDA?

LUNA 3D received FDA 510(k) clearance on 2024-03-29, under approval number K232031.

What company makes LUNA 3D?

LUNA 3D is manufactured by Lap GmbH Laser Applikationen.

What is the FDA product code for LUNA 3D?

The FDA product code for LUNA 3D is IYE.

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Official Source

View on FDA Database →

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

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