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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photocoagulator And Accessories
510(k) Number K110228
Device Name NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
Applicant
Nidek Incorporated
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Applicant Contact KIT CARIQUITAN
Correspondent
Nidek Incorporated
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Correspondent Contact KIT CARIQUITAN
Regulation Number886.4690
Classification Product Code
HQB  
Subsequent Product Code
HQF  
Date Received01/26/2011
Decision Date 02/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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