Cleared Traditional

xPORT 304 (miCOR) System Lens Fragmentation System

K200584 · Carl Zeiss Meditec Cataract Technology, Inc. · Ophthalmic
Jul 2020
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K200584 is an FDA 510(k) clearance for the xPORT 304 (miCOR) System Lens Fragmentation System, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Carl Zeiss Meditec Cataract Technology, Inc. (Reno, US). The FDA issued a Cleared decision on July 31, 2020, 147 days after receiving the submission on March 6, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K200584 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2020
Decision Date July 31, 2020
Days to Decision 147 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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