510(k) K152423

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy by Sunfire Industries, Inc. — Product Code LEJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2016
Date Received
August 26, 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