Psi/Eye-Ko, Inc.

Psi/Eye-Ko, Inc. specializes in ophthalmic surgical instruments. Their product range includes cannulas for corneal procedures like LASIK, infusion cannulas for intraocular applications, vitreoretinal micropicks for retinal surgery, peribulbar needles for regional anesthesia, irrigating cystotomes for cataract surgery, capsule polishers for lens cleaning, and sub-Tenon cannulas for periocular injections. These devices are designed for precision in eye surgeries.

Psi/Eye-Ko, Inc. is based in the United States. While their headquarters are in the US, their devices are engineered to comply with international regulatory standards, particularly those relevant to ophthalmic surgical instruments. This ensures their products meet the requirements of markets where they are distributed, including the EU.

Psi/Eye-Ko, Inc.’s devices are listed in the eudamed registry, which is the European database for medical devices. This registry is used to track devices that have been authorized for placement on the EU market, ensuring transparency and traceability for healthcare professionals and regulators.

Psi/Eye-Ko, Inc.’s devices fall under EU Class IIa, which is the second-lowest risk classification for medical devices. This classification applies to instruments that pose a moderate risk to patients, such as certain surgical tools used in ophthalmology. Class IIa devices require compliance with specific EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, including clinical evaluations and risk management processes.