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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K163176
Device Name Exilis XP II
Applicant
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Applicant Contact David Chmel
Correspondent
BTL Industries, Inc.
47 Loring Dr.
Framingham,  MA  01702
Correspondent Contact David Chmel
Regulation Number878.4400
Classification Product Code
PBX  
Date Received11/14/2016
Decision Date 01/12/2017
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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