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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 a medical device manufactured by Menicon Co, Ltd.. It received FDA 510(k) clearance on 2020-03-02 under approval 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. It is manufactured by Menicon Co, Ltd.. The 510(k) number is K191872.

When was Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution approved by the FDA?

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

What company makes Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution?

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is manufactured by Menicon Co, Ltd..

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

NCT07608211 Development of a Sanitizing Tablet for Removable Partial Dentures NOT_YET_RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07565350 Local Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts RECRUITING NCT07534865 Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts RECRUITING

Related PubMed Literature

PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025)

Other Devices by Menicon Co, Ltd.

K173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens K180004Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens K193399Miru 1day UpSide (midafilcon A) PMA P990018Lens, contact, orthokeratology, overnight

Related Devices (Code: LPN)

K161819NNR06 Multi-Purpose SolutionBausch & Lomb, Incorporated K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. K161622LensGiene Sterile Saline SolutionOptics Laboratory, Inc. K170483Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated K190674REFRESH RELIEVA For CONTACTSAllergan, Inc. K191795AOCup Lens Case with AODiscAlcon Laboratories, 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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