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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 K161043
Device Name Profound System
Applicant
Syneron Candela Corporation
530 Boston Post Rd.
Wayland,  MA  01778
Applicant Contact Ruthie Amir
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
GEI  
Date Received04/13/2016
Decision Date 09/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02489994
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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