China NMPA Product Recall - Semiconductor laser therapy device

The National Medical Products Administration (NMPA) announced a voluntary Level III recall by Luoyang Yilaikang Medical Device Co., Ltd. for its Semiconductor Laser Therapy Instruments (Model YLK-A10, batch number 20170602). This recall, initiated on October 9, 2018, was prompted by random inspection findings revealing significant non-compliance with product standards. The main issues included deficiencies in laser port size, laser power, laser protection category, laser window markings, and product identification details. These violations indicate a failure to meet the technical requirements for such medical devices. In response, Luoyang Yilaikang Medical Device Co., Ltd. immediately recalled the two affected units sold in China, submitting them to local regulatory authorities for disposal. The company also committed to a thorough investigation into the root causes of these non-compliances and to developing robust preventive and corrective measures to ensure future product quality.