Device Classification Name |
fat reducing low level laser
|
510(k) Number |
K160880 |
Device Name |
Photonica Professional |
Applicant |
Ward Photonics LLC |
1980 N Atlantic Avenue |
Cocoa Beach,
FL
32931
|
|
Applicant Contact |
Terry Ward |
Correspondent |
Alliance Lifescience Partnerships, LLC |
1260 Bell View Circle |
Sandy,
UT
84094
|
|
Correspondent Contact |
Jeff Brown |
Regulation Number | 878.5400
|
Classification Product Code |
|
Date Received | 03/30/2016 |
Decision Date | 09/23/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02867150
|
Reviewed by Third Party |
No
|
Combination Product |
No
|