Clearance Summary
OrthoPulse received FDA 510(k) clearance under submission number K143120, sponsored by Biolux Research , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-07-24.
- Submission: K143120
- Applicant / Sponsor: Biolux Research , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2015-07-24
Classification & Regulation
This clearance is catalogued under FDA product code PLH and 21 CFR 872.5470, within the Dental review panel as a Class II device.