Cleared Traditional

VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control (K203060) - 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 24
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K203060.
miCOR System Lens Fragmentation System
K222236 · Carl Zeiss Meditec Cataract Technology, Inc. · Aug 2022
EVA NEXUS Ophthalmic Surgical System
K213467 · D.O.R.C. Dutch Ophthalmic Research Center (International) · Jun 2022
QUATERA 700
K212241 · Carl Zeiss Meditec, AG · Apr 2022
xPORT S Lens Fragmentation System
K200207 · Carl Zeiss Meditec Cataract Technology, Inc. · Oct 2020
xPORT 304 (miCOR) System Lens Fragmentation System
K200584 · Carl Zeiss Meditec Cataract Technology, Inc. · Jul 2020
Visalis V500, Visalis S500
K193376 · Carl Zeiss Meditec, AG · Jun 2020