FDA 510(k)

Lente de RGP Escleral Ampleye (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

Número K: K172314 · 2017-09-20

RequerenteArt Optical Contact Lens, Inc.

Data da decisão2017-09-20

Código do produtoHQD

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is the device name listed in this FDA 510(k) record. The listed applicant is Art Optical Contact Lens, Inc.. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K172314. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Art Optical Contact Lens, Inc.. The 510(k) number is K172314.

When did Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) receive FDA 510(k) clearance?

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) received FDA 510(k) clearance on 2017-09-20, under 510(k) number K172314.

Who is the listed applicant for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

The FDA 510(k) record lists Art Optical Contact Lens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

The FDA product code for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is HQD.

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Fonte oficial

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