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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 K233804
Device Name Resonic Rapid Acoustic Pulse Device
Applicant
Zeltiq Aesthetics, Inc.
4410 Rosewood Dr.
Pleasanton,  CA  94588
Applicant Contact Vicky Chai
Correspondent
Zeltiq Aesthetics, Inc.
4410 Rosewood Dr.
Pleasanton,  CA  94588
Correspondent Contact Vicky Chai
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/29/2023
Decision Date 02/01/2024
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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