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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K133358
Device Name NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
Applicant
Nidek Co., Ltd.
Via Dell'Artigianato, 6/A
Albignasego (Padova),  IT 35020
Applicant Contact ENRICO BISSON
Correspondent
Nidek Co., Ltd.
Via Dell'Artigianato, 6/A
Albignasego (Padova),  IT 35020
Correspondent Contact ENRICO BISSON
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received10/31/2013
Decision Date 08/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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