Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K090094 |
FOIA Releasable 510(k) |
K090094
|
Device Name |
ZELTIQ SYSTEM |
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 |
|
Subsequent Product Codes |
|
Date Received | 01/14/2009 |
Decision Date | 05/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|