510(k) K151721
K151721 is an FDA 510(k) premarket notification submitted by Kdb Inc. (Dba) Sperti Sunlamp for the device "FIJI SUN FLUORESCENT TANNING UNIT". The FDA issued a decision of Substantially Equivalent on Jun 22, 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
- Jun 22, 2018
- Date Received
- Jun 25, 2015
- Clearance Type
- Abbreviated
- 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)