Clearance Summary
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products received FDA 510(k) clearance under submission number K151400, sponsored by Jk Holding GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2015-09-16.
- Submission: K151400
- Applicant / Sponsor: Jk Holding GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 2015-09-16
Classification & Regulation
This clearance is catalogued under FDA product code LEJ and 21 CFR 878.4635, within the General, Plastic Surgery review panel as a Class II device.