China NMPA Product Recall - Nd:YAG PicoWay Laser System

Candela Corporation, a medical device manufacturer, has announced a voluntary Class III recall for its PicoWay Laser Therapy Device. This action was reported by Syneron (Beijing) Medical Technology Co., Ltd. and publicly disseminated by the National Medical Products Administration (NMPA) on April 23, 2023. The recall stems from a specific manufacturing defect identified in certain product batches: the lens of the zoom handle was incorrectly inverted during the assembly process. This issue, while classified as Class III, indicates that the defect may not cause serious adverse health consequences but warrants immediate corrective action to maintain product quality and user confidence. The NMPA, operating under its regulatory framework, mandates that companies address such deviations to ensure the safety and efficacy of medical devices in the market. Candela Corporation's required action is to facilitate the recall of all affected PicoWay Laser Systems, identified by specific National Medical Device Registration Certificates (20173092289 and 20173242289). Detailed information regarding the precise models, specifications, and batch numbers subject to this recall is provided in an accompanying Medical Device Recall Event Report Form. This voluntary recall underscores the manufacturer's commitment to product quality and patient safety, aligning with NMPA's stringent oversight.