Cleared Traditional

Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism

K200528 · Bausch & Lomb, Incorporated · Ophthalmic
Jun 2020
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K200528 is an FDA 510(k) clearance for the Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on June 2, 2020, 92 days after receiving the submission on March 2, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K200528 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2020
Decision Date June 02, 2020
Days to Decision 92 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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