FDA 510(k)

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)

N.º K: K230124 · 2023-03-15

SolicitanteLight Tree Ventures Europe B.V.

Fecha de decisión2023-03-15

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2023-03-15 under 510(k) number K230124. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K230124.

When did LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) receive FDA 510(k) clearance?

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) received FDA 510(k) clearance on 2023-03-15, under 510(k) number K230124.

Who is the listed applicant for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)?

The FDA product code for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) is OHS.

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Fuente oficial

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