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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 K111493
Device Name NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
Original Applicant
NIDEK CO., LTD.
755 n. mathilda avenue
suite 100
sunnyvale,  CA  94085
Original Contact michael j billig
Regulation Number886.4390
Classification Product Code
HQF  
Date Received05/31/2011
Decision Date 07/27/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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