510(k) K152364

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS by Pc Marketing, Inc. — Product Code LEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2016
Date Received
August 21, 2015
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