510(k) K152364
K152364 is an FDA 510(k) premarket notification submitted by Pc Marketing, Inc. for the device "uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS". The FDA issued a decision of Substantially Equivalent on Apr 14, 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
- Apr 14, 2016
- Date Received
- Aug 21, 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
- 510(k)