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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fat Reducing Low Level Laser
510(k) Number K134040
Device Name BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
Applicant
BTL INDUSTRIES LTD
16 APPLETON STREET
WALTHAM,  MA  02453
Applicant Contact MICHAIL M PANKRATOV
Correspondent
BTL INDUSTRIES LTD
16 APPLETON STREET
WALTHAM,  MA  02453
Correspondent Contact MICHAIL M PANKRATOV
Regulation Number878.5400
Classification Product Code
OLI  
Date Received12/31/2013
Decision Date 09/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02023385
Reviewed by Third Party No
Combination Product No
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