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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K102266
Device Name ISOLED AC-POWERED LED HEADLIGHT SYSTEM
Applicant
Isolux, LLC
1045 Collier Center Way
Suite #6
Naples,  FL  34110
Applicant Contact NIKOLAUS ANDREOULAKIS
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Regulation Number878.4580
Classification Product Code
FST  
Subsequent Product Code
HPQ  
Date Received08/10/2010
Decision Date 09/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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