Device Classification Name |
Fat Reducing Low Level Laser
|
510(k) Number |
K130922 |
Device Name |
ERCHONIA VERJU LASER SYSTEM WITH MASSAGER |
Applicant |
ERCHONIA MEDICAL, INC. |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
ERCHONIA MEDICAL, INC. |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 878.5400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/03/2013 |
Decision Date | 05/17/2013 |
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
|