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FDA 510(k)

Miru 1day UpSide (midafilcon A)

K-Number: K193399 · 2020-06-17

ApplicantMenicon Co, Ltd.
Decision Date2020-06-17
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Miru 1day UpSide (midafilcon A) 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 2020-06-17 under 510(k) number K193399. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miru 1day UpSide (midafilcon A)?

Miru 1day UpSide (midafilcon A) is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K193399.

When did Miru 1day UpSide (midafilcon A) receive FDA 510(k) clearance?

Miru 1day UpSide (midafilcon A) received FDA 510(k) clearance on 2020-06-17, under 510(k) number K193399.

Who is the listed applicant for Miru 1day UpSide (midafilcon A)?

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 Miru 1day UpSide (midafilcon A)?

The FDA product code for Miru 1day UpSide (midafilcon A) is LPL.

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 wearK191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionK180819One 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: LPL)

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.

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.K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision Corporation

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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