Laon Ortho
FDA 510(k) K250198 · Laon Medi, Inc.
510(k) numberK250198
Submission
- Device name
- Laon Ortho
- Applicant
- Laon Medi, Inc.
Gwacheon-Si, KR - Received
- January 23, 2025
- Decision date
- April 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNN – Orthodontic Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5470
- Specialty
- Dental
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.
Other 510(k)s with product code PNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260419 | LingOral Dental Design SystemPNN · Traditional | Hangzhou ChohoTech Co., Ltd. | 05/08/2026SE |
| K253565 | SureSmile SoftwarePNN · Traditional | Dentsply Sirona, Inc. | 03/04/2026SE |
| K252507 | SmileInspectorPNN · Traditional | Amv Consulting, LLC | 01/07/2026SE |
| K253343 | Celebrace SoftwarePNN · Traditional | Celebrace | 12/29/2025SE |
| K241153 | Progressive Orthodontics AppPNN · Traditional | Progressive Aligners, Inc. | 10/11/2024SE |
| K233625 | Raydent SWPNN · Traditional | Ray Co., Ltd. | 05/16/2024SE |
| K232564 | Align StudioPNN · Traditional | Laon Medi, Inc. | 03/12/2024SE |
| K233616 | Clevaligner Software (V1.0.0)PNN · Traditional | Clevaligner, Ltd. | 01/11/2024SE |
| K232549 | NemoCastPNN · Traditional | Software Nemotec S.L. | 11/21/2023SE |
| K232429 | Titan Dental DesignPNN · Traditional | Clearadvance, LLC | 10/13/2023SE |
More from Clearadvance, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K232564 | Align StudioPNN · Traditional | 03/12/2024SE |
Questions and answers
When was Laon Ortho cleared by the FDA?
Laon Ortho (K250198) received a 510(k) decision of Substantially Equivalent on April 23, 2025, 90 days after the submission was received.
What is the product code of K250198?
The FDA product code is PNN – Orthodontic Software, a Class II (moderate risk) device regulated under 21 CFR 872.5470.