Cleared Traditional

xPORT S Lens Fragmentation System

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

About This 510(k) Submission

K200207 is an FDA 510(k) clearance for the xPORT S 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 October 15, 2020, 261 days after receiving the submission on January 28, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K200207 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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