Device Classification Name |
fat reducing low level laser
|
510(k) Number |
K172111 |
Device Name |
Vevazz LED |
Applicant |
Vevazz, LLC |
3839 McKinney Ave. |
#251 |
Dallas,
TX
75204
|
|
Applicant Contact |
Jamie Fettig |
Correspondent |
Vevazz, LLC |
3839 McKinney Ave. |
#251 |
Dallas,
TX
75204
|
|
Correspondent Contact |
Jamie Fettig |
Regulation Number | 878.5400
|
Classification Product Code |
|
Date Received | 07/13/2017 |
Decision Date | 11/22/2017 |
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
|