Bausch and Lomb, Incorporated FDA Approvals

0 new drug approvals and 2 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
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)510(k)Mar 25, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Mar 25, 2026
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)510(k)Jul 26, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Jul 26, 2024