Medical Device Manufacturer · US , Santa Ana , CA

Johnson & Johnson Surgical Vision, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2019

Recent clearances: ELITA™ Femtosecond Laser System, ELITA™ Patient Interface, VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control, UNFOLDER Vitan Inserter

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Johnson & Johnson Surgical Vision, Inc. Ophthalmic ✕

4 devices

1-4 of 4

Cleared Apr 14, 2023

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface

Ophthalmic · 136d

Cleared Mar 12, 2021

VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and...

Ophthalmic · 155d

Cleared Sep 13, 2019

UNFOLDER Vitan Inserter

Ophthalmic · 53d

Cleared Aug 16, 2019

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT...

Ophthalmic · 28d