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 ROAD |
PLEASANTON,
CA
94588
|
|
Applicant Contact |
DONALD V JOHNSON |
Correspondent |
ZELTIQ AESTHETICS |
4698 WILLOW ROAD |
PLEASANTON,
CA
94588
|
|
Correspondent Contact |
DONALD V JOHNSON |
Regulation Number | 878.4810
|
Classification Product Code |
|
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
|