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FDA 510(k)

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist

K-Number: K151918 · 2016-02-11

ApplicantBausch & Lomb, Incorporated
Decision Date2016-02-11
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist is a medical device manufactured by Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2016-02-11 under approval number K151918. 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 Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist?

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist is a medical device that received FDA 510(k) clearance on 2016-02-11. It is manufactured by Bausch & Lomb, Incorporated. The 510(k) number is K151918.

When was Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist approved by the FDA?

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist received FDA 510(k) clearance on 2016-02-11, under approval number K151918.

What company makes Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist?

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist is manufactured by Bausch & Lomb, Incorporated.

What is the FDA product code for Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist?

The FDA product code for Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist is LPL.

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Related Devices (Code: LPL)

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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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