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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 K151569
Device Name Tranberg CLS Laser Fiber
Applicant
Clinical Laserthermia Systems, AB
Scheelevagen 2
Lund,  SE 223 81
Applicant Contact Lars Erik Eriksson
Correspondent
Omedtech, LLC
1725 Signal Ridge Dr., Suite 150
Edmond,  OK  73013
Correspondent Contact David Makanani
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/10/2015
Decision Date 02/12/2016
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
Recalls CDRH Recalls
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