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FDA 510(k)

LAIA XR

K-Number: K251577 · 2026-02-06

Decision Date2026-02-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LAIA XR is the device name listed in this FDA 510(k) record. The listed applicant is Augmented Reality Software S.L.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) 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. The listed applicant is Augmented Reality Software S.L.. The 510(k) number is K251577.

When did LAIA XR receive FDA 510(k) clearance?

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

Who is the listed applicant for LAIA XR?

The FDA 510(k) record lists Augmented Reality Software S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAIA XR?

The FDA product code for LAIA XR is LLZ.

Related Devices (Code: LLZ)

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.

Official Source

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