Stetic Medical Aesthetics Development (Shenzhen) Co. , Ltd

Stetic Medical Aesthetics Development (Shenzhen) Co., Ltd specializes in home-use cosmetic red-light phototherapy systems. These devices are designed for aesthetic treatments, such as skin rejuvenation or improvement, and are intended for consumer use in a home setting. Examples include the STETIC SENSE, HOMEDICS, and DUO series.

The company is based in the United States. While the name includes 'Shenzhen,' the operational headquarters and regulatory presence are in the US, where its devices are developed and marketed.

Stetic Medical’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries track medical devices that have undergone the required premarket notification process (510(k)) and are assigned a UDI for traceability and compliance purposes.

Stetic Medical’s cosmetic red-light phototherapy systems fall under Class II classification in regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.