Cleared Abbreviated

PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

K050948 · Bausch & Lomb, Inc. · Ophthalmic
May 2005
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K050948 is an FDA 510(k) clearance for the PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, 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 May 18, 2005, 33 days after receiving the submission on April 15, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K050948 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2005
Decision Date May 18, 2005
Days to Decision 33 days
Submission Type Abbreviated
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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