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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Fiberoptic, Surgical Field
510(k) Number K163185
Device Name OptiLux LED Illuminator
Applicant
Isolux, LLC
1045 Collier Center Way
Suite #6
Naples,  FL  34110
Applicant Contact NIKOLAOS ANDREOULAKIS
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number878.4580
Classification Product Code
HBI  
Date Received11/14/2016
Decision Date 11/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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