510(k) K152405
K152405 is an FDA 510(k) premarket notification submitted by Ibl Acquisitions, LLC for the device "IBL 5000 Tanning Booth". The FDA issued a decision of Substantially Equivalent on September 1, 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
- September 1, 2016
- Date Received
- August 25, 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