FDA 510(k)

LUNA 3D

Número K: K232031 · 2024-03-29

Data da decisão2024-03-29

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2024-03-29 under 510(k) number K232031. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LUNA 3D?

LUNA 3D is a medical device that received FDA 510(k) clearance on 2024-03-29. The listed applicant is Lap GmbH Laser Applikationen. The 510(k) number is K232031.

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

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

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.

Outros registros que listam Lap GmbH Laser Applikationen como candidato(a)

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.

K253004LUNA 3D K200907Thales 3D Mr Scanner K173926DORADOnova MR3T

Dispositivos Relacionados (Código: IYE)

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Fonte oficial

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