FDA 510(k)

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)

N.º K: K171404 · 2017-07-17

Fecha de decisión2017-07-17

Código de productoHQD

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is the device name listed in this FDA 510(k) record. The listed applicant is Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2017-07-17 under 510(k) number K171404. 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 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is a medical device that received FDA 510(k) clearance on 2017-07-17. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K171404.

When did BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) receive FDA 510(k) clearance?

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) received FDA 510(k) clearance on 2017-07-17, under 510(k) number K171404.

Who is the listed applicant for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

The FDA 510(k) record lists Bausch + Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

The FDA product code for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is HQD.

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Otros registros que enlistan a Bausch + Lomb, Incorporated como solicitante

K230954Samfilcon B Custom Contact Lens K211786Independent Corneal Viewing Chamber (IVC-21)K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism

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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