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FDA 510(k)

LAIA XR

K-Number: K251577 · 2026-02-06

ApplicantAugmented Reality Software S.L.
Decision Date2026-02-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LAIA XR is a medical device manufactured by Augmented Reality Software S.L.. It received FDA 510(k) clearance on 2026-02-06 under approval number K251577. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAIA XR?

LAIA XR is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Augmented Reality Software S.L.. The 510(k) number is K251577.

When was LAIA XR approved by the FDA?

LAIA XR received FDA 510(k) clearance on 2026-02-06, under approval number K251577.

What company makes LAIA XR?

LAIA XR is manufactured by Augmented Reality Software S.L..

What is the FDA product code for LAIA XR?

The FDA product code for LAIA XR is LLZ.

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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.

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