510(k) K152412

T-32;T-40;T-44;T-52;T-72;TT-50 by Tanses Technologies, Inc. — Product Code LEJ

K152412 is an FDA 510(k) premarket notification submitted by Tanses Technologies, Inc. for the device "T-32;T-40;T-44;T-52;T-72;TT-50". The FDA issued a decision of Substantially Equivalent on April 29, 2016. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Tanses Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 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