Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Led Accessory
Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
- Companies listing it
- 33 makers
- Brands and models
- 6
- 510(k) clearances
- 21 in five years
- FDA name
- Orthodontic Led Accessory
510(k) clearances per year, 1976–2026
Companies that list PLH
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Biolux Technology GmbH | Austria | Maker | OrthoPulse · OrthoPulse - Extended - Gen 2 · OrthoPulse - Standard - Gen 2 · OrthoPulse Lite | 1 | 2023 |
| Creanova doo | Serbia | Maker | OrthoPulse- Extended - Gen 2 | — | — |
| Manterra Technologies Inc | Canada | Maker | OrthoPulse Lite | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 9 Jun 2023 | K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH |
| 24 Jul 2015 | K143120 | OrthoPulse | Biolux Research , Ltd. |
Official records: FDA product classification for PLH · 21 CFR 872.5470.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026