Eye-Novation LLC

Eye-Novation LLC specializes in medical device disinfection solution containers, specifically designed for ophthalmic use. Their primary product, the Tonowash system, is intended for cleaning and disinfecting reusable ophthalmic instruments and devices to maintain sterile conditions in clinical settings.

Eye-Novation LLC is based in the United States. The company’s products are developed and manufactured within the US regulatory framework.

Eye-Novation LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring traceability and compliance with regulatory requirements.

Eye-Novation LLC’s devices fall under the FDA’s Class II regulatory category. This classification applies to products that generally pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness.