Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia— 510(k) K210975

Clearance details

Applicant

Bausch & Lomb, Incorporated

Product code

Code LPL

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

2021-04-01

Decision date

2021-05-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

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• K242389 — EyeGility Inserter for Preloaded enVista IOLs2024-10-10
• K230954 — Samfilcon B Custom Contact Lens2023-11-17
• K220613 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia2023-03-08
• K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops2022-12-06
• K211786 — Independent Corneal Viewing Chamber (IVC-21)2021-12-03

Injury

988

Other

4

Total

992

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →