Device Classification Name |
Fat Reducing Low Level Laser
|
510(k) Number |
K243811 |
Device Name |
Erchonia Zerona® VZ8 |
Applicant |
Erchonia Corporation |
112 Southchase Blvd |
Fountain Inn,
SC
29644
|
|
Applicant Contact |
Travis Sammons |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 878.5400
|
Classification Product Code |
|
Date Received | 12/11/2024 |
Decision Date | 01/10/2025 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|