LaonMedi’s ‘Laon Ortho’ Receives U.S. FDA Clearance — One-Click Workflow Boosts Clinical Efficiency

“AI-Powered Clear Aligner Technology Positioned for Rapid Growth in the U.S. Dental Market”

LaonMedi, the AI healthcare subsidiary of LaonPeople (CEO Suk-Joong Lee), has received U.S. FDA clearance for newly added features of its AI dental clear-aligner software ‘Laon Ortho.’

Laon Ortho is an AI-driven clear-aligner treatment planning software that segments teeth—including roots—from CBCT (Cone Beam CT) scan data and reconstructs them into a detailed 3D view. The product, recently rebranded as “Laon Ortho,” has now obtained FDA approval for newly added functionalities required for U.S. market distribution.

The newly approved capability is the “One-Click Clear Aligner Setup”, which streamlines the orthodontic planning process. With a single click, clinicians can rapidly generate an initial treatment plan—whether extraction or non-extraction—significantly improving chairside efficiency and accelerating decision-making.

Additional newly cleared features include:

• Timeline-Based Precision Treatment Planning:
  Enables clinicians to set the timing and sequence of individual tooth movements, supporting highly detailed and systematic treatment planning.

• Cloud-Based Data Management:
  All treatment data can be stored and accessed via the cloud, allowing clinicians, treatment coordinators, and dental labs to review 3D treatment plans in real time anywhere within the clinic.

• Extraction & Pontic Workflow Support:
  Facilitates predictable treatment planning for complex cases involving extractions, missing teeth, or pontics, improving both aesthetic outcomes and procedural predictability.

A LaonMedi spokesperson said,

“By adding advanced capabilities to Laon Ortho and successfully passing the FDA’s rigorous evaluation process, we expect strong growth in the U.S. medical market as AI-driven clear aligner adoption accelerates.”

Earlier, LaonMedi secured KRW 4.85 billion in investment, reflecting a company valuation of KRW 30 billion, based on its proprietary technologies. The company has also strengthened its global competitiveness with 12 patents and six certifications, establishing itself as a leading innovator in AI orthodontic solutions.