510(k) · Cleared
ClearedOrthoPulse 2.0E (OPi2E-100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolux Technology GmbH · PLH Orthodontic Led Accessory
Cleared on Jun 9, 2023 as substantially equivalent to K143120 (Biolux Research, Ltd., 2015) after a 70-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jun 9, 2023
- Review
- 70 days
- Class
- Class II
- Product code
- PLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924975 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK924975 The OrthotrainerMyofunctional Research Corp. Pty., Ltd. · 1993
- 3 generations backK110661 AcceledentOrthoaccel Technologies, Inc. · 2011
- 2 generations backK130643 Acceledent AuraOrthoaccel Technologies, Inc. · 2013
- 1 generation backK143120 OrthoPulseBiolux Research, Ltd. · 2015
- This deviceK230905 OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924975 | The Orthotrainer | Myofunctional Research Corp. Pty., Ltd. | 1993 | — |
| −3 | K110661 | Acceledent | Orthoaccel Technologies, Inc. | 2011 | — |
| −2 | K130643 | Acceledent Aura | Orthoaccel Technologies, Inc. | 2013 | — |
| −1 | K143120 | OrthoPulse | Biolux Research, Ltd. | 2015 | — |
| 0 (this device) | K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143120 | OrthoPulseSummary page 4…n name: Orthodontic LED Accessory (21 CFR 872.5470) Regulatory Class: II Product Code: PLH III. Predicate Device Name of the device: OrthoPulse, K143120 (Primary predicate) Classification name: Orthodontic LED Accessory (21 CFR 872.5470) Regulatory Class: II Product Code:… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K143120.
How does its category compare?
All PLH devicesPLH Orthodontic Led Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PLH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PLH
Too few PLH 510(k)s in any year since 2007 to give a median.
Recalls per year · PLH
No recall names PLH since 2007.
Adverse event reports per year · PLH
1in 2024
MAUDE reports naming product code PLH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230905: OrthoPulse 2.0E (OPi2E-100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230905
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026