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FDA 510(k)

BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI

K-Number: K122575 · 2012-12-20

ApplicantBausch & Lomb, Inc.
Decision Date2012-12-20
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI 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 2012-12-20 under 510(k) number K122575. 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 PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI?

BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K122575.

When did BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI receive FDA 510(k) clearance?

BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI received FDA 510(k) clearance on 2012-12-20, under 510(k) number K122575.

Who is the listed applicant for BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI?

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 BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI?

The FDA product code for BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI is LPL.

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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.

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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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