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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 K152737
Device Name Lite Touch
Applicant
Focus Medical, LLC
23 Francis J Clarke Circle
Bethel,  CT  06801
Applicant Contact JOHN B LEE
Correspondent
Focus Medical, LLC
23 Francis J Clarke Circle
Bethel,  CT  06801
Correspondent Contact JOHN B LEE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/23/2015
Decision Date 06/29/2016
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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