Clearance Summary
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 received FDA 510(k) clearance under submission number K152452, sponsored by Medtek Lighting Corp D/B/A Peacock Tanning. 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 2016-05-19.
- Submission: K152452
- Applicant / Sponsor: Medtek Lighting Corp D/B/A Peacock Tanning
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 2016-05-19
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.