ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE


Device Classification Name

powered laser surgical instrument

510(k) Number K080118
Device Name ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
Applicant
ZELTIQ AESTHETICS
4698 willow road
pleasanton, 
CA 
94588

Applicant Contact donald v johnson
Correspondent
ZELTIQ AESTHETICS
4698 willow road
pleasanton, 
CA 
94588

Correspodent Contact donald v johnson
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/17/2008
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