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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 K062721
Device Name GREENTON ECOLITE IPL SYSTEM
Applicant
Greenton (London) , Ltd.
5818 Princess Caroline Place
Leesburg,  FL  34748
Applicant Contact ROBERT T HANDREN
Correspondent
Greenton (London) , Ltd.
5818 Princess Caroline Place
Leesburg,  FL  34748
Correspondent Contact ROBERT T HANDREN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/12/2006
Decision Date 11/21/2006
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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