(90 days)
Not Found
No
The document explicitly states "Not Found" for "Mentions AI, DNN, or ML" and describes the software as performing "automatic segmentation" and providing "basic model analysis" without any indication of AI, machine learning, or deep learning being used for these functions. The performance testing section only confirms the software meets criteria and functions without errors, not specifically through AI methods.
No
The device is described as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options." It assists in planning and analysis but does not directly treat a disease or condition.
Yes
Explanation: The device provides "systematic inspection" and "detailed analysis" based on 3D models of the patient's dentition, which are diagnostic functions. It also provides "basic model analysis" to assist digital orthodontic procedures.
Yes
The device is a software-only medical device because the description explicitly states "Laon Ortho is a PC-based software" and no hardware components are mentioned, nor is there any verification/validation described for hardware. The software processes digital impressions and image data, and performance studies focus solely on software validation and performance.
No
The device is described 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 3D models of the patient's dentition". It processes digital impressions and image data like CT scans to assist digital orthodontic procedures. This function is related to diagnosis and treatment planning based on anatomical structures, not on analyzing specimens derived from the human body to provide information for diagnosis or monitoring of diseases.
N/A
Intended Use / Indications for Use
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 3D models 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.
Product codes (comma separated list FDA assigned to the subject device)
PNN, LLZ
Device Description
Laon Ortho is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface scan from STL file, CT image data(DICOM), 2D overlay(PNG, JPG, BMP)
Anatomical Site
Dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1) Software Validation
Laon Ortho contains Basic Documentation Level software. Software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: Content of premarket submissions for Device Software Functions, on November 04, 2021.
2) Performance Testing
Through the performance test, it was confirmed that Laon Ortho meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - Laon Ortho
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 23, 2025
LAON MEDI Inc.
Mina Yun
Quality Management Representative (QMR)
60 Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840
C-504
Gwacheon-si, Gyeonggi-do 13840
SOUTH KOREA
Re: K250198
Trade/Device Name: Laon Ortho
Regulation Number: 21 CFR 872.5470
Regulation Name: Orthodontic Plastic Bracket
Regulatory Class: Class II
Product Code: PNN, LLZ
Dated: January 23, 2025
Received: January 23, 2025
Dear Mina Yun:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K250198 - Mina Yun Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K250198 - Mina Yun Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K250198
Device Name: Laon Ortho
Indications for Use (Describe)
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 3D models 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.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/
Page 1 / 6
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
Jan 23, 2025
2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]
- Name of Manufacturer: LAON MEDI Inc.
- Address: C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea / Tel: +82 2 507 8990
- Contact Name: Mina Yun
- Telephone No.: +82 2 507 8993
- Fax No.: +82 2 507 8997
- Email Address: may@laon-medi.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade name: Laon Ortho
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Orthodontic Software | 872.5470 | PNN |
| System, Image Processing, Radiological | 892.2050 | LLZ |
As stated in 21 CFR, parts 872.5470 and 892.2050, this generic types of devices has been classified as Class II.
Page 6
C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/
Page 2 / 6
4. Identification of Predicate Device(s) [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 Name: Align Studio
Predicate device #2
- 510(k) Number: K180941
- Applicant: 3Shape A/S
- Classification Name: Orthodontic Software
- Trade Name: Ortho System
5. Description of the Device [21 CFR 807.92(a)(4)]
Laon Ortho is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.
6. Indications for Use [21 CFR 807.92(a)(5)]
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 3D models 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.
Page 7
C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/
Page 3 / 6
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences between Laon Ortho and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision | |
|---|---|---|---|---|
| K Number | - | K232564 | K180941 | - |
| Manufacturer | LAON MEDI Inc. | LAON MEDI Inc. | 3Shape A/S | - |
| Model | Laon Ortho | Align Studio | Ortho System | - |
| Intended Use | 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 3D models 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. | The Align Studio 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 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Align Studio 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. | Ortho System™ for dental retainers and dental cast for sequential aligners 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 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Ortho System™ 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. | Same as predicate devices |
| Module | Imports scanned image of patient | Imports scanned image of patient | Imports scanned image of patient | Same as predicate devices |
| Stand-alone software module | Stand-alone software module | Stand-alone software module | ||
| Can be used to design dental casts | Can be used to design dental casts | Can be used to design dental casts | ||
| Useful for diagnosis, treatment planning, and CAD design | Useful for diagnosis, treatment planning, and CAD design | Useful for diagnosis, treatment planning, and CAD design |
Page 8
C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/
Page 4 / 6
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision | |
|---|---|---|---|---|
| Virtual planning of tooth movement | Virtual planning of tooth movement | Virtual planning of tooth movement | ||
| Supports .stl files | Supports .stl files | Supports .stl files | ||
| Managing patient and case base data | Creating, editing, deleting and copying patient data | Creating, editing, deleting and copying patient data | Creating, editing, deleting and copying patient data | Same as predicate devices |
| Creating, editing, deleting and copying case data | Creating, editing, deleting and copying case data | Creating, editing, deleting and copying case data | ||
| Collection of study material | Surface scan from STL file | Surface scan from STL file | Surface scan from STL file | Same as predicate device #2 |
| CT image data(DICOM) | CT image data(DICOM) | CT image data(DICOM) | ||
| 2D overlay(PNG, JPG, BMP) | - | 2D overlay(PNG, JPG, BMP) | ||
| Creation of virtual 3D virtual dental models | Creation of virtual 3D virtual dental models | Creation of virtual 3D virtual dental models | ||
| Alignment of study material | Aligning surface scan or CT image | Aligning surface scan or CT image | Aligning surface scan or CT image | Same as predicate device #2 |
| Aligning cephalometric images | Aligning cephalometric images | Aligning cephalometric images | ||
| Alignment of 2D overlays | - | Alignment of 2D overlays | ||
| Ability to check/adjust DICOM visibility | Ability to check/adjust DICOM visibility | Ability to check/adjust DICOM visibility | ||
| Analyzing study material | Definition of dental Arch shape & length | Definition of dental Arch shape & length | Definition of dental Arch shape & length | Same as predicate device #1 |
| - | - | Wire length | ||
| Tooth width measurements | Tooth width measurements | Tooth width measurements | ||
| Tooth and gingiva separation/segmentation | Tooth and gingiva separation/segmentation | - | ||
| Bolton's analysis | Bolton's analysis | Bolton's analysis | ||
| Space analysis | Space analysis | Space analysis | ||
| Overjet/overbite | Overjet/overbite | Overjet/overbite |
Page 9
C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/
Page 5 / 6
| Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision | |
|---|---|---|---|---|
| Occlusal mapping | Occlusal mapping | Occlusal mapping | ||
| Treatment simulation | - | - | 2D simulation | Same as predicate device #1 |
| 3D simulation | 3D simulation | 3D simulation | ||
| Treatment Planning Workflow | Manual Mode | Manual Mode | Manual Mode | Similar |
| Automatic Simulation Mode | - | - |
Similar
The device proposed for 510(k) is Laon Ortho, a modification of the predicate device Align Studio (K232564, cleared on March 12, 2024). The proposed device includes the addition of an Automatic Simulation Mode. However, this change doesn't alter the existing workflow. The results of the verification and validation (V&V) testing showed that the Automatic Mode achieves the same treatment planning as the existing workflow. Therefore, this change does not affect substantially equivalence on safety and effectiveness.
Page 10
C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/
Page 6 / 6
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
1) Software Validation
Laon Ortho contains Basic Documentation Level software. Software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: Content of premarket submissions for Device Software Functions, on November 04, 2021.
2) Performance Testing
Through the performance test, it was confirmed that Laon Ortho meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device.
Clinical Test Summary [21 CFR 807.92(b)(2)]
Not Applicable
Conclusion [21 CFR 807.92(b)(3)]
Based on a comparison of intended use, indications, principle of operations, features and technical data, and the test results, the Laon Ortho is found to be as safe and as effective as the predicate device. Intended use and performance is found to be substantially equivalent to the predicate device, Align Studio (K232564) from LAON MEDI Inc. and Ortho System (K180941) from 3Shape A/S.