Cleared Traditional

VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control

K203060 · Johnson & Johnson Surgical Vision, Inc. · Ophthalmic

Mar 2021

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K203060 is an FDA 510(k) clearance for the VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Johnson & Johnson Surgical Vision, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 12, 2021, 155 days after receiving the submission on October 8, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K203060 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 2020
Decision Date	March 12, 2021
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF