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FDA 510(k)

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

N.º K: K210975 · 2021-05-24

SolicitanteBausch & Lomb, Incorporated
Fecha de decisión2021-05-24
Código de productoLPL
Comité asesorOP
DecisiónSubstantially Equivalent

Resumen del dispositivo

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia 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 2021-05-24 under 510(k) number K210975. 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 (hydrophilic) Contact Lens for Presbyopia?

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is a medical device that received FDA 510(k) clearance on 2021-05-24. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K210975.

When did Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia receive FDA 510(k) clearance?

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia received FDA 510(k) clearance on 2021-05-24, under 510(k) number K210975.

Who is the listed applicant for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia?

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 (hydrophilic) Contact Lens for Presbyopia?

The FDA product code for Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is LPL.

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

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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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