FDA 510(k)

MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

N.º K: K253795 · 2026-08-13

Fecha de decisión2026-08-13

Código de productoLPN

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is the device name listed in this FDA 510(k) record. The listed applicant is Menicon Co, Ltd.. It received FDA 510(k) clearance on 2026-08-13 under 510(k) number K253795. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution?

MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K253795.

When did MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution receive FDA 510(k) clearance?

MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution received FDA 510(k) clearance on 2026-08-13, under 510(k) number K253795.

Who is the listed applicant for MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution?

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

What is the FDA product code for MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution?

The FDA product code for MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is LPN.

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Otros registros que enlistan a Menicon Co, Ltd. como solicitante

K262495Miru 1day UpSide (midafilcon A)K193399Miru 1day UpSide (midafilcon A)K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens K180004Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens K173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

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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.