Medical Device Manufacturer · US , Rodchester , NY

Bausch and Lomb, Incorporated - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2018

Recent clearances: Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E), Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455), Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bausch and Lomb, Incorporated Ophthalmic ✕

3 devices

1-3 of 3

Cleared Mar 25, 2026

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455,...

Ophthalmic · 267d

Cleared Jul 26, 2024

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

Ophthalmic · 186d

Cleared Mar 27, 2018

Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance...

Ophthalmic · 50d