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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 K980547
Device Name NIDEK PRIMA MODEL GYC-1500/2000
Applicant
Nidek, Inc.
47651 Westinghouse Dr.
Fremont,  CA  94539
Applicant Contact KEN KATO
Correspondent
Nidek, Inc.
47651 Westinghouse Dr.
Fremont,  CA  94539
Correspondent Contact KEN KATO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/12/1998
Decision Date 05/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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