510(k) · Cleared
ClearedOrthoPulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolux Research, Ltd. · PLH Orthodontic Led Accessory
Cleared on Jul 24, 2015 as substantially equivalent to K110661 (Orthoaccel Technologies, Inc., 2011) and 1 other predicate after a 267-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it.
- Decided
- Jul 24, 2015
- Review
- 267 days
- Class
- Class II
- Product code
- PLH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K924975 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK924975 The OrthotrainerMyofunctional Research Corp. Pty., Ltd. · 1993
- 2 generations backK110661 AcceledentOrthoaccel Technologies, Inc. · 2011
- 1 generation backK130643 Acceledent AuraOrthoaccel Technologies, Inc. · 2013
- This deviceK143120 OrthoPulseBiolux Research, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK153048 AcceleDent AuraOrthoaccel Technologies, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK230905 OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK183018 VPro5Propel Orthodontics, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK170093 AcceleDent OptimaOrthoaccel Technology, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K153048AcceleDent AuraOrthoaccel Technologies, Inc. · 2016 · cites it directly2descendants
- K230905OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH · 2023 · cites it directly0descendants
- K183018VPro5Propel Orthodontics, LLC · 2019 · 2 generations on0descendants
- K170093AcceleDent OptimaOrthoaccel Technology, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924975 | The Orthotrainer | Myofunctional Research Corp. Pty., Ltd. | 1993 | — |
| −2 | K110661 | Acceledent | Orthoaccel Technologies, Inc. | 2011 | — |
| −1 | K130643 | Acceledent Aura | Orthoaccel Technologies, Inc. | 2013 | — |
| 0 (this device) | K143120 | OrthoPulse | Biolux Research, Ltd. | 2015 | — |
| +1 | K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. | 2016 | — |
| +1 | K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | 2023 | — |
| +2 | K183018 | VPro5 | Propel Orthodontics, LLC | 2019 | — |
| +2 | K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
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.
Top candidate predicates for a new PLH device
- #1 K230905 OrthoPulse 2.0E (OPi2E-100)score 6.4 · 4 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K110661 | AcceledentSummary page 4…ED Accessory (PLH) Classification Name/Classification Orthodontic plastic bracket, 21 CFR 872.5470, Class II Predicate Devices OrthoAccel’s Acceledent (K110661, K130643) This predicate has not been subject to a design-related recall. Intended Use / Indications for U… | 2011 |
| * | K130643 | Acceledent AuraSummary page 4…ory (PLH) Classification Name/Classification Orthodontic plastic bracket, 21 CFR 872.5470, Class II Predicate Devices OrthoAccel’s Acceledent (K110661, K130643) This predicate has not been subject to a design-related recall. Intended Use / Indications for Use… | 2013 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K153048 (Orthoaccel Technologies, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K110661.
How does its category compare?
All PLH devicesPLH Orthodontic Led Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143120: OrthoPulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143120
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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