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

K152423 is an FDA 510(k) premarket notification submitted by Sunfire Industries, Inc. for the device "Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy". The FDA issued a decision of Substantially Equivalent on May 20, 2016. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635.

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