LASER PHARMACEUTICALS

Laser Pharmaceuticals specializes in skin semi-occlusive dressings that are non-antimicrobial, such as products like B&C Ointment. These devices are formulated to create a protective barrier over skin wounds, helping maintain moisture balance and support healing without antimicrobial additives.

Laser Pharmaceuticals is based in the United States, meaning its devices fall under U.S. medical device regulations administered by the FDA. Since the company’s products are classified as Class I devices, they are subject to the FDA’s general controls, including registration, listing, and compliance with quality system requirements.

Laser Pharmaceuticals’ devices are included in the FDA’s Unique Device Identification (UDI) system, which is a centralized database for tracking medical devices in the U.S. This system helps ensure traceability and transparency in the supply chain, aligning with FDA requirements for Class I devices.

Laser Pharmaceuticals’ devices are classified as FDA Class I, which means they pose the lowest risk among medical devices. This classification is determined by the FDA based on the device’s intended use and potential harm—here, skin dressings like B&C Ointment are considered low-risk due to their non-invasive, non-antimicrobial nature. Class I devices typically require general controls (e.g., registration, labeling) rather than stringent pre-market approvals.