510(k) K162763

Vevazz LED Heat Lamp by Vevazz, LLC — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2017
Date Received
September 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type