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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 K222629
Device Name Resonic Rapid Acoustic Pulse Device
Applicant
Zeltiq Aesthetics, Inc.
(Acquired Soliton, Inc. Through Parent Company Abbvie)
4410 Rosewood Dr.
Pleasanton,  CA  94588
Applicant Contact Saurabh Jamkhindikar
Correspondent
Zeltiq Aesthetics, Inc.
4410 Rosewood Dr.
Pleasanton,  CA  94588
Correspondent Contact Saurabh Jamkhindikar
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/31/2022
Decision Date 09/25/2022
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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