Huadong Medicine's Primelase Laser Device Registration Accepted by China's NMPA

On the evening of September 14, 2026, Huadong Medicine (000963) announced that China's National Medical Products Administration (NMPA) had accepted the registration application for Primelase, a Class III medical device semiconductor laser treatment system. Primelase is developed by High Technology Products S. L. U. , a wholly owned subsidiary of Huadong Medicine, and is based on semiconductor laser technology. The device features adjustable multiple parameters, supporting combinations of different wavelengths, spot sizes and output parameters for a range of clinical applications. Primelase has obtained market access approvals in multiple countries and regions worldwide. It was first launched in Europe in 2014, received US FDA approval in December 2019, and has achieved sales and clinical use across Europe, North America, Latin America, Asia-Pacific, the Middle East and Africa. Dongguan Securities forecast the 2024 to 2028 period for the device's market outlook, according to the announcement's reference to the forecast period. Primelase is equipped with seven treatment handpieces covering two main areas: hair removal and benign cutaneous vascular lesions. For hair removal, the configuration includes one 755nm wavelength handpiece (20x9 spot size), three 810nm handpieces (20x9, 30x9 and 30x17 spot sizes), and two mixed-wavelength 810+940+1060nm handpieces (20x9 and 30x9 spot sizes), totaling six. Treatment of vascular lesions is handled by one 1060nm handpiece (4x3 spot size). The multi-wavelength and multi-spot-size design allows physicians to select treatment parameters based on factors such as the patient's skin color, hair diameter, treatment area and skin type. Overseas clinical data show that Primelase has relevant data in hair removal and vascular lesion treatment. In hair removal applications, hair reduction rates after multiple treatments ranged from 47% to 69%, with 61% of treatment sites achieving more than 75% hair reduction. For vascular lesion treatment, most improvements ranged from 51% to 100%. Adverse reactions were predominantly mild to moderate and mostly resolved within 48 hours.