Laser Health Technologies, LLC

Laser Health Technologies, LLC specializes in Class II medical devices designed for home-use musculoskeletal and physical therapy. Their primary product category includes low-level laser therapy devices, such as the LaserTouchOne series, which are intended for localized pain relief and tissue stimulation in non-clinical environments. These devices are not intended for clinical or professional medical use but are authorised for consumer application.

Laser Health Technologies, LLC is based in the United States. While the exact location is not specified, the company’s regulatory filings and device listings are submitted under the US jurisdiction, indicating its operational base is within the country.

Laser Health Technologies, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries document the authorised status of their Class II medical devices, ensuring compliance with FDA requirements for pre-market clearance and device tracking. The inclusion in these registries confirms their regulatory authorisation for home-use physical therapy applications.

Laser Health Technologies, LLC’s devices fall under the FDA’s Class II classification. This classification is assigned based on the risk level of the device, where Class II devices generally pose moderate risk and require special controls—such as pre-market notification (510(k)) submissions—to ensure safety and effectiveness. Their musculoskeletal/physical therapy lasers are authorised under this classification due to their intended use for non-invasive, home-based pain relief and tissue stimulation.