[Edaily Reporter Kwon Oh Seok ] Raon Medi, a subsidiary of LaonPeople Inc.(300120)and a company specializing in artificial intelligence (AI) digital orthodontic solutions, announced on the 22nd that it has obtained regulatory approval in Japan for its proprietary orthodontic software and is accelerating its expansion into the local market.

Raon Medi announced that its AI-based orthodontic software, “Laon Ortho,” has passed the technical, safety, and efficacy reviews conducted by the Pharmaceuticals and Medical Devices Agency (PMDA)—an agency under Japan’s Ministry of Health, Labor and Welfare—and has received final approval. The company has also secured its first batch of orders.
This approval and product supply are considered highly significant, as they represent a successful commercialization that goes beyond mere overseas exports and overcomes the regulatory hurdles of Japan’s medical device and medical software market, which is renowned for its strict standards. In Japan, where demand for the transition to digital healthcare is rising sharply due to an aging population and a shortage of medical personnel, Laon Medi’s official validation of its technological capabilities and safety is expected to accelerate its expansion of market share in the region.
Previously, Raon Medi signed a partnership agreement with Corefront, a Japanese distributor specializing in medical devices, to enter the local market. Corefront has been conducting local testing and sales activities through pre-orders since last August and will begin full-scale expansion of its distribution network immediately upon regulatory approval. Analysts note that RaonOrtho’s technological differentiation—such as the creation of precise digital orthodontic treatment plans through AI analysis of oral data—is resonating well with local medical professionals.
A Raon Medi official explained, “With the Japanese regulatory approval process now complete and additional order volumes secured, we have entered the full-scale commercialization phase,” adding, “We will build a business model optimized for the Japanese orthodontic market by leveraging customized digital solutions that integrate data analysis and AI technology.” The official further noted, “Using our collaboration with Corefront as a springboard, we will establish meaningful references and expand our reach into the global digital orthodontics market.”
Having entered the North American market through approval from the U.S. Food and Drug Administration (FDA), Raon Medi plans to further strengthen its global growth momentum by leveraging this approval from Japan’s Ministry of Health, Labor and Welfare and the establishment of a local distribution network.