Cleared Traditional

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

K242801 · Carl Zeiss Meditec Cataract Technology, Inc. · Ophthalmic

Jun 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K242801 is an FDA 510(k) clearance for the MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185), 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 June 11, 2025, 267 days after receiving the submission on September 17, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K242801 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2024
Decision Date	June 11, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement