# K230905: OrthoPulse 2.0E (OPi2E-100)

- Pathway: 510(k) (Special)
- Applicant: Biolux Technology GmbH
- Decided: Jun 9, 2023 after 70 days
- Product code: PLH (Orthodontic Led Accessory)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924975 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143120: OrthoPulse, Biolux Research, Ltd. (2015) Summary page 4.

## Indications for use
The OrthoPulse® device is intended to accelerate orthodontic movement of teeth which may reduce the overall treatment time for the patient. The OrthoPulse® device is intended for use during orthodontic treatment. The device is intended to be used in conjunction with traditional orthodontic treatment with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

Source page: https://510kreport.com/device/K230905
Methodology: https://510kreport.com/methodology