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FDA 510(k)

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism

N.º K: K200528 · 2020-06-02

SolicitanteBausch + Lomb, Incorporated
Fecha de decisión2020-06-02
Código de productoLPL
Comité asesorOP
DecisiónSubstantially Equivalent

Resumen del dispositivo

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism 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 2020-06-02 under 510(k) number K200528. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism?

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K200528.

When did Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism receive FDA 510(k) clearance?

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism received FDA 510(k) clearance on 2020-06-02, under 510(k) number K200528.

Who is the listed applicant for Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism?

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 Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism?

The FDA product code for Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism is LPL.

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

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K230954Samfilcon B Custom Contact LensK211786Independent Corneal Viewing Chamber (IVC-21)K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)

Dispositivos relacionados (Código: LPL)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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