Clearance Summary
Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy received FDA 510(k) clearance under submission number K152423, sponsored by Sunfire Industries, 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 2016-05-20.
- Submission: K152423
- Applicant / Sponsor: Sunfire Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 2016-05-20
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.