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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K243395
Device Name MICOR 700 with Auto I/A
Applicant
Carl Zeiss Meditec Cataract Technology, Inc.
8740 Technology Way
Reno,  NV  89521
Applicant Contact Andrew Rybold
Correspondent
GSM Services, Inc.
49 Coastal Oak
Aliso Viejo,  CA  92656
Correspondent Contact Gary Mocnik
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
MLZ  
Date Received10/31/2024
Decision Date 08/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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