510(k) K152452

Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 by Medtek Lighting Corp D/B/A Peacock Tanning — Product Code LEJ

K152452 is an FDA 510(k) premarket notification submitted by Medtek Lighting Corp D/B/A Peacock Tanning for the device "Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200". The FDA issued a decision of Substantially Equivalent on May 19, 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 19, 2016
Date Received
August 28, 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