Cleared Traditional

MICOR Lens Fragmentation System

K214028 · Carl Zeiss Meditec Cataract Technology, Inc. · Ophthalmic
Sep 2022
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K214028 is an FDA 510(k) clearance for the MICOR 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 September 9, 2022, 261 days after receiving the submission on December 22, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K214028 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2021
Decision Date September 09, 2022
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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