Legrand Associates

Legrand Associates specializes in custom-made ocular prosthetics and related fitting aids. Their primary products include eyeball prostheses, ophthalmic conformers, and scleral shells. These devices are tailored to individual patients who have undergone enucleation or evisceration, offering both functional and cosmetic support. The conformers and scleral shells also serve as transitional solutions during the healing process before a permanent prosthesis is fitted.

Legrand Associates is based in the United States. Since they operate domestically, their devices must comply with U.S. medical device regulations, including classification under the FDA’s regulatory framework. The company’s products fall into Class I and Class II categories, which determine the level of oversight and compliance requirements based on the associated risk.

Yes, Legrand Associates’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing helps ensure traceability, transparency, and compliance with U.S. regulatory standards. The UDI system allows healthcare providers, regulators, and patients to easily identify and verify the specific devices in use, supporting safer and more efficient medical practices.

Legrand Associates’ devices are classified as either Class I or Class II under the FDA’s regulatory system. Class I devices generally pose the lowest risk and may require minimal regulatory controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification reflects the level of oversight needed to mitigate potential risks associated with each product.