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FDA 510(k)

NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS

K-Number: K112192 · 2011-10-25

ApplicantBausch & Lomb, Inc.
Decision Date2011-10-25
Product CodeMVN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2011-10-25 under 510(k) number K112192. The device is classified under product code MVN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS?

NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS is a medical device that received FDA 510(k) clearance on 2011-10-25. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K112192.

When did NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS receive FDA 510(k) clearance?

NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS received FDA 510(k) clearance on 2011-10-25, under 510(k) number K112192.

Who is the listed applicant for NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS?

The FDA 510(k) record lists Bausch & Lomb, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS?

The FDA product code for NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS is MVN.

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Other records listing Bausch & Lomb, Inc. 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.

K192005Bausch + Lomb PreVue Inserter for enVista PreloadedK173480Crystalsert Lens Delivery SystemK161012Easy-Load Lens Delivery SystemK131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIK113852BAUSCH & LOMB IOL INJECTOR

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Related Devices (Code: MVN)

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.

K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact LensHOYA Lamphun , Ltd.K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.K130331SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKERSauflon Pharmaceuticals, Ltd.K080632CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENSClearlab SG Pte, Ltd.K080755SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENSBausch & Lomb, 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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