FDA 510(k)

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens

Número K: K170335 · 2017-03-24

Data da decisão2017-03-24

Código do produtoHQD

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Valley Contax, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K170335. 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 Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens?

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Valley Contax, Inc.. The 510(k) number is K170335.

When did Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens receive FDA 510(k) clearance?

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens received FDA 510(k) clearance on 2017-03-24, under 510(k) number K170335.

Who is the listed applicant for Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens?

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

What is the FDA product code for Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens?

The FDA product code for Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens is HQD.

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Outros registros que listam Valley Contax, Inc. como candidato(a)

K213880Custom Stable Rigid Gas Permeable Scleral Contact Lens K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

Dispositivos Relacionados (Código: HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) e Acuity 181™ (tisilfocon A) com Tangible™ Hydra-PEG® Rígido Gas Permeável Lentes de ContatoAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight K240618Acuity 200® (fluoroxyfocon A) Lente de Contato Rígida e Permeável ao Gás; Acuity 100® (hexafocon A) Lente de Contato Rígida e Permeável ao Gás; Acuity 200® com Tangible® Hydra-PEG® (fluoroxyfocon A) Lente de Contato Rígida e Permeável ao Gás; Acuity 100® com Tangible® Hydra-PEG® (hexafocon A) Lente de Contato Rígida e Permeável ao GásAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

Fonte oficial

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