Cleared Traditional

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

K122575 · Bausch & Lomb, Inc. · Ophthalmic
Dec 2012
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K122575 is an FDA 510(k) clearance for the BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on December 20, 2012, 119 days after receiving the submission on August 23, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K122575 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2012
Decision Date December 20, 2012
Days to Decision 119 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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