Cleared Traditional

MICOR 700 with Auto I/A

K243395 · Carl Zeiss Meditec Cataract Technology, Inc. · Ophthalmic
Aug 2025
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K243395 is an FDA 510(k) clearance for the MICOR 700 with Auto I/A, 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 8, 2025, 281 days after receiving the submission on October 31, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K243395 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2024
Decision Date August 08, 2025
Days to Decision 281 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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