Clearance Summary
3400E series; E5400 series; E6400 series; Sundazzler series received FDA 510(k) clearance under submission number K151905, sponsored by Heartland Tanning, Inc.. 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 2016-03-01.
- Submission: K151905
- Applicant / Sponsor: Heartland Tanning, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 2016-03-01
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.