510(k) K151962

KBL Sunlamp Products (= Device Bundling name) by Kbl AG — Product Code LEJ

K151962 is an FDA 510(k) premarket notification submitted by Kbl AG for the device "KBL Sunlamp Products (= Device Bundling name)". The FDA issued a decision of Substantially Equivalent on September 15, 2016. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Kbl AG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2016
Date Received
July 16, 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