510(k) · Cleared
ClearedLaon Ortho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laon Medi, Inc. · PNN Orthodontic Software
Cleared on Apr 23, 2025 as substantially equivalent to K232564 (Laon Medi, Inc., 2024) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 2009.
- Decided
- Apr 23, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K082207 (2009). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK082207 Orthocad IQCadent, Inc. · 2009
- 4 generations backK152086 3Shape Ortho System3Shape A/S · 2016
- 3 generations backK171295 ULab Systems Treatment Planning SoftwareUlab Systems, Inc. · 2018
- 2 generations backK180941 Ortho System3Shape A/S · 2018
- 1 generation backK232564 Align StudioLaon Medi, Inc. · 2024
- This deviceK250198 Laon OrthoLaon Medi, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| −4 | K152086 | 3Shape Ortho System | 3Shape A/S | 2016 | — |
| −3 | K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018 | — |
| −2 | K180941 | Ortho System | 3Shape A/S | 2018 | — |
| −1 | K232564 | Align Studio | Laon Medi, Inc. | 2024 | — |
| 0 (this device) | K250198 | Laon Ortho | Laon Medi, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 PNN? 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 PNN device
- #1 K262196 Invisalign Systemscore 14.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K232564 | Align StudioSummary page 6…) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device #1 510(k) Number: K232564 Applicant: LAON MEDI Inc. Classification Name: Orthodontic Software Trade… | 2024 |
| * | K180941 | Ortho SystemSummary page 6… Classification Name: Orthodontic Software Trade Name: Align Studio Predicate device #2 510(k) Number: K180941 Applicant: 3Shape A/S Classification Name: Orthodontic Software Trade Nam… | 2018 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PNN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNN
177in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PNN
1in 2024
MAUDE reports naming product code PNN, 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 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 5 | 229 | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 7 | 221 | 0 | 0 |
| 2021 | 4 | 58 | 1 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 3 | 90 | 0 | 0 |
| 2024 | 4 | 177 | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
The Laon Ortho is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment.
The use of the Laon Ortho requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software .
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250198: Laon Ortho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250198
Report an extraction error
Are you the manufacturer?
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