Biolux Research , Ltd.

Biolux Research, Ltd. specializes in professional red-light phototherapy units, such as the OrthoPulse device. These devices are engineered for medical applications, leveraging red-light therapy to address specific clinical needs. The focus is on Class II devices, which are regulated under FDA guidelines for moderate-risk medical equipment.

Biolux Research, Ltd. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including mandatory registration in the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. This ensures compliance with U.S. medical device authorization requirements.

Biolux Research, Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that the company’s Class II devices meet FDA safety and effectiveness standards by showing substantial equivalence to a legally marketed predicate device. The UDI system ensures traceability and transparency in the supply chain, which is critical for post-market surveillance and regulatory compliance.

Biolux Research, Ltd.’s devices, including the OrthoPulse, are classified as Class II under FDA regulations. This classification indicates they pose moderate risks and require special controls beyond general controls to ensure safety and performance. While Class II devices still undergo rigorous review, they do not require the same level of pre-market approval as Class III devices, which are higher risk.