510(k) K181455

ProSun sunlamp products, Luxura sunlamp products by Prosun International, LLC — Product Code LEJ

K181455 is an FDA 510(k) premarket notification submitted by Prosun International, LLC for the device "ProSun sunlamp products, Luxura sunlamp products". The FDA issued a decision of Substantially Equivalent on September 10, 2018. 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
September 10, 2018
Date Received
June 4, 2018
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