Cleared Special

miCOR System Lens Fragmentation System

K222236 · Carl Zeiss Meditec Cataract Technology, Inc. · Ophthalmic
Aug 2022
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K222236 is an FDA 510(k) clearance for the 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 August 24, 2022, 29 days after receiving the submission on July 26, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K222236 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2022
Decision Date August 24, 2022
Days to Decision 29 days
Submission Type Special
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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