FDA 510(k) clearance · back to tracker

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

Bausch + Lomb, Inc. cleared K262941 on 2026-10-16, decision: substantially equivalent

K-number

K262941

Sponsor

Bausch + Lomb, Inc.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-16

Product code

LPL

Advisory committee

Ophthalmic

Medical specialty

Ophthalmic

Regulation number

886.5925

Official FDA record

Open K262941on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K262941 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.