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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K131894
Device Name NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
Applicant
Nidek Co., Ltd.
34-14 Maehama
Hiroishi-Cho
Gamagori,  JP 443-0038
Applicant Contact YONEJI MIZUNO
Correspondent
Nidek Co., Ltd.
34-14 Maehama
Hiroishi-Cho
Gamagori,  JP 443-0038
Correspondent Contact YONEJI MIZUNO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/25/2013
Decision Date 10/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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