Device Classification Name |
fat reducing low level laser
|
510(k) Number |
K121690 |
Device Name |
ETCHONIA ZERONA ARMS |
Applicant |
ERCHONIA CORPORATION |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
ERCHONIA CORPORATION |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 878.5400
|
Classification Product Code |
|
Date Received | 06/07/2012 |
Decision Date | 08/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|