Cleared Traditional

K203060 - VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203060 · Johnson & Johnson Surgical Vision, Inc. · Ophthalmic device
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Mar 2021
Decision
155d
Days
Class 2
Risk

K203060 is an FDA 510(k) clearance for the VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advan.... Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Johnson & Johnson Surgical Vision, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 12, 2021 after a review of 155 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Johnson & Johnson Surgical Vision, Inc. devices

Submission Details

510(k) Number K203060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 110d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 314
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