FDA applicant
Bausch & Lomb, Inc.
FDA records 163 decisions for Bausch & Lomb, Inc. (Rochester, NY) from 1971 to 2026: 132 510(k) clearances and 31 original PMA approvals. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and LPN (Accessories, Soft Lens Products). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 126 predicates, 74 of them its own earlier devices. 74 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Bausch & Lomb, Incorporated”, “Bausch & Lomb”, “Bausch + Lomb, Incorporated”, “Bausch+Lomb”, “Bausch + Lomb, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bausch & Lomb, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Bausch & Lomb, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Bausch”
FDA records each applicant name separately; these may or may not be the same firm.