510(k) K161394

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux by Sportarredo Group S.C. — Product Code LEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2017
Date Received
May 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Booth, Sun Tan
Device Class
Class II
Regulation Number
878.4635
Review Panel
SU
Submission Type