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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 K200584
Device Name xPORT 304 (miCOR) System Lens Fragmentation System
Applicant
Carl Zeiss Meditec Cataract Technology Inc
8748 Technology Way
Reno,  NV  89521
Applicant Contact Gary Mocnik
Correspondent
Carl Zeiss Meditec Cataract Technology Inc
8748 Technology Way
Reno,  NV  89521
Correspondent Contact Gary Mocnik
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
MLZ  
Date Received03/06/2020
Decision Date 07/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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