Clearance Summary
OrthoPulse 2.0E (OPi2E-100) received FDA 510(k) clearance under submission number K230905, sponsored by Biolux Technology GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-06-09.
- Submission: K230905
- Applicant / Sponsor: Biolux Technology GmbH
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2023-06-09
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.