Bausch & Lomb, Incorporated FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
EyeGility Inserter for Preloaded enVista IOLs510(k)Oct 10, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Oct 10, 2024
Samfilcon B Custom Contact Lens510(k)Nov 17, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Nov 17, 2023
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 Presbyopia510(k)Mar 8, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Mar 8, 2023
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops510(k)Dec 6, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Dec 6, 2022
Independent Corneal Viewing Chamber (IVC-21)510(k)Dec 3, 2021	—	510(k)Substantially Equivalent (Traditional)	Dec 3, 2021
ABT12 multi-purpose solution510(k)May 28, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	May 28, 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia510(k)May 24, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	May 24, 2021