FDA 510(k)

Lente de Contacto Rígida Gas Permeable Acuity 200 con Tangible Hydra-PEG (fluoroxyfocon A)

N.º K: K213538 · 2021-12-30

Fecha de decisión2021-12-30

Código de productoHQD

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Polymers, Inc.. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K213538. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K213538.

When did Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens receive FDA 510(k) clearance?

Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens received FDA 510(k) clearance on 2021-12-30, under 510(k) number K213538.

Who is the listed applicant for Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

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

What is the FDA product code for Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens?

The FDA product code for Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is HQD.

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Otros registros que enlistan a Acuity Polymers, Inc. como solicitante

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Dispositivos relacionados (Código: HQD)

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Lentes de Contacto Rígidas Gas Permeables Acuity 181™ (tisilfocon A) y Acuity 181™ (tisilfocon A) con Tangible™ Hydra-PEG®Acuity 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 K240618Lente de Contacto Rígida Gas Permeable Acuity 200™ (fluoroxyfocon A); Lente de Contacto Rígida Gas Permeable Acuity 100™ (hexafocon A); Lente de Contacto Rígida Gas Permeable Acuity 200™ con Tangible® Hydra-PEG® (fluoroxyfocon A); Lente de Contacto Rígida Gas Permeable Acuity 100™ con Tangible® Hydra-PEG® (hexafocon A)Acuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

Fuente oficial

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