Liceguard, LLC

Liceguard, LLC specializes in devices for head lice treatment, specifically powered lice combs and lice removal/prevention kits. These products are designed to mechanically remove lice and nits from hair, intended for use in both clinical and home settings. The focus is on addressing head lice infestations through physical removal rather than chemical treatments.

Liceguard, LLC is based in the United States, which means its devices fall under FDA jurisdiction. Since the company’s products are classified as Class I medical devices, they are subject to the FDA’s general controls, including registration, listing, and compliance with quality system requirements. The U.S. location also means the devices must adhere to FDA’s Unique Device Identifier (UDI) system, ensuring traceability and transparency in the regulatory database.

Liceguard’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is part of the FDA’s efforts to improve device tracking, transparency, and post-market surveillance. Listing in the UDI database helps ensure that authorized devices can be easily identified and verified by healthcare providers, regulators, and patients.

Liceguard’s devices are classified as Class I medical devices under FDA regulations. This classification applies to products that pose minimal risk to users, such as powered lice combs and removal kits. Class I devices typically require the least regulatory oversight, focusing primarily on general controls like good manufacturing practices and labeling requirements. The classification reflects the low risk associated with these products, which primarily function through mechanical means rather than invasive or high-risk procedures.