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FDA 510(k)

Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens

N.º K: K213216 · 2022-01-18

SolicitanteUnicon Optical Co., Ltd.
Fecha de decisión2022-01-18
Código de productoLPL
Comité asesorOP
DecisiónSubstantially Equivalent

Resumen del dispositivo

Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Unicon Optical Co., Ltd.. It received FDA 510(k) clearance on 2022-01-18 under 510(k) number K213216. 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 Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens?

Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is Unicon Optical Co., Ltd.. The 510(k) number is K213216.

When did Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens receive FDA 510(k) clearance?

Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens received FDA 510(k) clearance on 2022-01-18, under 510(k) number K213216.

Who is the listed applicant for Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens?

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

What is the FDA product code for Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens?

The FDA product code for Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is LPL.

Ensayos clínicos relacionados

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Otros registros que enlistan a Unicon Optical Co., Ltd. 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.

K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensK182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac

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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