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FDA 510(k)

BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS

K-Number: K132715 · 2013-12-20

ApplicantBausch & Lomb, Incorporated
Decision Date2013-12-20
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132715. 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 BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS?

BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K132715.

When did BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS receive FDA 510(k) clearance?

BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132715.

Who is the listed applicant for BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS?

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

What is the FDA product code for BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS?

The FDA product code for BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS 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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