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FDA 510(k)

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

N.º K: K242916 · 2025-02-04

SolicitanteLargan Medical Co., Ltd.
Fecha de decisión2025-02-04
Código de productoLPL
Comité asesorOP
DecisiónSubstantially Equivalent

Resumen del dispositivo

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Largan Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-02-04 under 510(k) number K242916. 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 Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2025-02-04. The listed applicant is Largan Medical Co., Ltd.. The 510(k) number is K242916.

When did Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens receive FDA 510(k) clearance?

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2025-02-04, under 510(k) number K242916.

Who is the listed applicant for Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

The FDA 510(k) record lists Largan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

The FDA product code for Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is LPL.

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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

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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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