Cleared Traditional

K193376 - Visalis V500

K193376 is the FDA 510(k) clearance for Visalis V500 by Carl Zeiss Meditec, AG. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K193376 · Carl Zeiss Meditec, AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
193d
Days
Class 2
Risk

K193376 is an FDA 510(k) clearance for the Visalis V500, Visalis S500. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on June 15, 2020 after a review of 193 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 Carl Zeiss Meditec, AG devices

Submission Details

510(k) Number K193376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2019
Decision Date June 15, 2020
Days to Decision 193 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
83d slower than avg
Panel avg: 110d · This submission: 193d
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 80
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K193376.
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. · Mar 2021
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
Phacoemulsification Needle (Tip) and Irrigation Sleeve
K192418 · Raico, LLC · May 2020
LEGION System
K191650 · Alcon Research, LLC · Nov 2019
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
K190875 · D.O.R.C. Dutch Ophthalmic Research Center (International) · Sep 2019