Clearance Summary
High Pressure Tanning Lamps received FDA 510(k) clearance under submission number K152141, sponsored by Blv Licht-Und Vakuumtechnik 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 2016-02-25.
- Submission: K152141
- Applicant / Sponsor: Blv Licht-Und Vakuumtechnik GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 2016-02-25
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.