Avedro, a Glaukos Company

Avedro manufactures excimer laser systems designed for corneal refractive surgery. These include devices for procedures like LASIK, photorefractive keratectomy (PRK), and accelerated corneal treatments to address conditions such as myopia, hyperopia, and astigmatism. The company also produces the KXL System, a corneal cross-linking device used specifically for treating keratoconus and other corneal ectasias.

Avedro is based in the United States. While the company’s devices are subject to regulatory oversight in the US, its excimer laser systems and the KXL System are also listed in the EUDAMED database, indicating their presence and compliance considerations in the European market.

Under EU regulations, Avedro’s devices are classified as either Class I or Class IIa. These classifications determine the level of scrutiny and regulatory requirements for each device type, with Class IIa typically involving additional safety and performance evaluations compared to Class I.

Yes, Avedro’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. Listing in EUDAMED ensures transparency and compliance with EU regulatory requirements, allowing healthcare professionals, regulators, and patients to verify the device’s legal status and key details like manufacturer information and classification.

Avedro’s excimer laser systems are primarily used for reshaping the cornea to correct vision issues such as myopia (nearsightedness), hyperopia (farsightedness), and astigmatism. The KXL System, on the other hand, is specifically designed for corneal cross-linking, a procedure that strengthens the cornea’s structure to treat progressive conditions like keratoconus or other corneal ectasias.