# K143120: OrthoPulse

- Pathway: 510(k) (Traditional)
- Applicant: Biolux Research, Ltd.
- Decided: Jul 24, 2015 after 267 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: 3 generations back to K924975 (1993). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110661: Acceledent, Orthoaccel Technologies, Inc. (2011) Summary page 4.
- K130643: Acceledent Aura, Orthoaccel Technologies, Inc. (2013) Summary page 4.

## Most influential descendants
- K153048: AcceleDent Aura (2016), 2 descendants of its own
- K230905: OrthoPulse 2.0E (OPi2E-100) (2023), 0 descendants of its own
- K183018: VPro5 (2019), 0 descendants of its own
- K170093: AcceleDent Optima (2017), 0 descendants of its own

## Indications for use
The OrthoPulseTM device is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

Source page: https://510kreport.com/device/K143120
Methodology: https://510kreport.com/methodology