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FDA 510(k)

SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS

K-Number: K061157 · 2006-06-22

ApplicantBausch & Lomb
Decision Date2006-06-22
Product CodeMVN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb. It received FDA 510(k) clearance on 2006-06-22 under 510(k) number K061157. 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 SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS?

SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS is a medical device that received FDA 510(k) clearance on 2006-06-22. The listed applicant is Bausch & Lomb. The 510(k) number is K061157.

When did SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS receive FDA 510(k) clearance?

SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS received FDA 510(k) clearance on 2006-06-22, under 510(k) number K061157.

Who is the listed applicant for SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS?

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

What is the FDA product code for SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS?

The FDA product code for SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS is MVN.

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Other records listing Bausch & Lomb as applicant

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K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+K232084Stellaris Elite vision enhancement systemK132481EASY-LOAD LENS DELIVERY SYSTEMK132593CRYSTALSERT DELIVERY SYSTEMK123736CRYSTALSERT DELIVERY SYSTEMK040913NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)

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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.K112192NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENSBausch & Lomb, Inc.K080632CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENSClearlab SG Pte, Ltd.

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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