Laserneedle GmbH

Laserneedle GmbH specializes in professional musculoskeletal and physical therapy lasers. Their primary focus is on handheld laser devices like the Laserneedle Touch and LASERNEEDLE Touch, which are designed for therapeutic applications. Additionally, they produce accessories such as silicone applicators, silicone pads, self-adhesive applicators, silicone protection caps, regular optical fibers, and laser safety goggles to support safe and effective laser therapy.

Laserneedle GmbH is based in Germany. The company’s location in Germany aligns with European regulatory standards, which may influence the classification and compliance requirements for their devices.

Laserneedle GmbH’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices within the European Union. Additionally, their devices are included in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance in the United States.

Laserneedle GmbH’s devices fall into three regulatory classes: Class I, Class II, and Class IIa. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, lower-risk items like laser safety goggles may qualify as Class I, while more complex therapeutic lasers like the Laserneedle Touch could be Class II or IIa due to their intended medical applications and potential risks.

Laserneedle GmbH’s devices appear in both eudamed and the FDA’s UDI system because they are marketed in both the European Union and the United States. The EU requires device listings in eudamed for compliance with its Medical Device Regulation (MDR), while the FDA mandates UDI registration for devices sold in the U.S. to ensure transparency, traceability, and regulatory oversight.