Aesthetic Technology, Ltd.

Aesthetic Technology, Ltd. specializes in phototherapy lamps that use blue, red, and infrared light. These devices are primarily designed for medical and aesthetic applications, such as skin rejuvenation, acne treatment, and tissue stimulation. The company’s portfolio includes the Dermalux series, which features multiple models like the Dermalux Tri-Wave MD, Dermalux Flex MD, and their variants, each tailored for specific clinical or patient needs.

Aesthetic Technology, Ltd. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. Since the company’s products are classified as Class II medical devices, they undergo evaluation through pathways like the 510(k) clearance process and the Unique Device Identification (UDI) system to ensure compliance with US medical device regulations.

Aesthetic Technology, Ltd.’s devices are tracked in the FDA’s regulatory databases, specifically through the 510(k) clearance process and the Unique Device Identification (UDI) system. These registries ensure traceability and compliance for Class II devices like the Dermalux series, which are authorised for medical and aesthetic use in the US.

Aesthetic Technology, Ltd.’s devices are classified as Class II medical devices in the US. This classification requires manufacturers to demonstrate that their products are substantially equivalent to a legally marketed predicate device through pathways like the 510(k) clearance, ensuring they meet safety and performance standards before being authorised for use.