Cleared Traditional

xPORT S Lens Fragmentation System (K200207) - FDA 510(k) Clearance

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

K200207 · Carl Zeiss Meditec Cataract Technology, Inc. · Ophthalmic device
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Oct 2020
Decision
261d
Days
Class 2
Risk

K200207 is an FDA 510(k) clearance for the xPORT S Lens Fragmentation System. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Carl Zeiss Meditec Cataract Technology, Inc. (Reno, US). The FDA issued a Cleared decision on October 15, 2020 after a review of 261 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 Cataract Technology, Inc. devices

Submission Details

510(k) Number K200207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2020
Decision Date October 15, 2020
Days to Decision 261 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 110d · This submission: 261d
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 K200207.
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
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 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
Phacoemulsification Needle (Tip) and Irrigation Sleeve
K192418 · Raico, LLC · May 2020