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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 K080118
FOIA Releasable 510(k) K080118
Device Name ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
Applicant
Zeltiq Aesthetics
4698 Willow Rd.
Pleasanton,  CA  94588
Applicant Contact DONALD V JOHNSON
Correspondent
Zeltiq Aesthetics
4698 Willow Rd.
Pleasanton,  CA  94588
Correspondent Contact DONALD V JOHNSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/17/2008
Decision Date 05/02/2008
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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