FDA 510(k)

LAIA XR

Número K: K251577 · 2026-02-06

RequerenteAugmented Reality Software S.L.

Data da decisão2026-02-06

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Dispositivos Relacionados (Código: LLZ)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.