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The Tracker / October 2026 / K262941

510(k) cleared

Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens

Bausch + Lomb, Inc. · Oct 16, 2026 · K262941

FDA cleared the Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens from Bausch + Lomb, Inc. on Oct 16, 2026 under K262941, a traditional 510(k). The device falls under product code LPL, Lenses, Soft Contact, Daily Wear, regulated at 21 CFR 886.5925 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Aug 21, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Bausch + Lomb, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262941?

K262941 is the FDA 510(k) for Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens, submitted by Bausch + Lomb, Inc.. FDA's decision date was Oct 16, 2026, under product code LPL (Lenses, Soft Contact, Daily Wear).

Who makes the Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens?

Bausch + Lomb, Inc., based in Rochester, NY, is the applicant of record for K262941.

How long did the K262941 review take?

FDA received the submission on Aug 21, 2026 and issued its decision on Oct 16, 2026, 56 days later.

← All decisions in October 2026