510(k) K230905
K230905 is an FDA 510(k) premarket notification submitted by Biolux Technology GmbH for the device "OrthoPulse 2.0E (OPi2E-100)". The FDA issued a decision of Substantially Equivalent on June 9, 2023. The device falls under product code PLH (Orthodontic Led Accessory), a Class II device regulated under 21 CFR 872.5470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 2023
- Date Received
- March 31, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthodontic Led Accessory
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.