510(k) K160880

Photonica Professional by Ward Photonics, LLC — Product Code OLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2016
Date Received
March 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fat Reducing Low Level Laser
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Non-invasive reduction in fat layer for body contouring