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FDA 510(k)

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

Número K: K210300 · 2021-04-01

RequerenteVuesonic, LLC
Data da decisão2021-04-01
Código do produtoLYL
Comité consultivoOP
DecisãoSubstantially Equivalent

Resumo do dispositivo

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is the device name listed in this FDA 510(k) record. The listed applicant is Vuesonic, LLC. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K210300. The device is classified under product code LYL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Vuesonic, LLC. The 510(k) number is K210300.

When did VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System receive FDA 510(k) clearance?

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System received FDA 510(k) clearance on 2021-04-01, under 510(k) number K210300.

Who is the listed applicant for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

The FDA 510(k) record lists Vuesonic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System?

The FDA product code for VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System is LYL.

Ensaios clínicos relacionados

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Dispositivos Relacionados (Código: LYL)

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.

K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd.

Fonte oficial

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