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FDA 510(k)

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution

K-Number: K191872 · 2020-03-02

ApplicantMenicon Co, Ltd.
Decision Date2020-03-02
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Menicon 3% Hydrogen Peroxide Cleaning and 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 2020-03-02 under 510(k) number K191872. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K191872.

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

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution received FDA 510(k) clearance on 2020-03-02, under 510(k) number K191872.

Who is the listed applicant for Menicon 3% Hydrogen Peroxide Cleaning and 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 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

The FDA product code for Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is LPN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07534865Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral WartsRECRUITING

Other records listing Menicon Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionPMA P990018Lens, contact (rigid gas permeable), extended wearK193399Miru 1day UpSide (midafilcon A)K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensK180004Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact LensK173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses

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Related Devices (Code: LPN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd.K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, IncorporatedK221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc.K202932ABT12 multi-purpose solutionBausch & Lomb, IncorporatedK210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLCK193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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