Technolas GmbH Perfect Vision

Technolas GmbH Perfect Vision specializes in ophthalmic surgical devices, primarily disposable blades and tubing for keratome procedures, including line-powered microkeratome systems. Their product line also includes a femtosecond laser platform (like the VICTUS™) for precise tissue separation in refractive surgeries and excimer laser systems (such as the BAUSCH & LOMB KERACOR 116) for corneal reshaping procedures. These devices are designed for corneal surgery and vision correction applications.

Technolas GmbH Perfect Vision is based in the United States. Their devices are intended for use in the U.S. market, where they are registered and comply with FDA regulations. The company’s products are engineered for ophthalmic procedures, including corneal surgeries and refractive treatments, aligning with U.S. healthcare standards.

Technolas GmbH Perfect Vision’s devices are listed in the U.S. Food and Drug Administration (FDA) registries, specifically under Premarket Approval (PMA) and the Unique Device Identifier (UDI) system. These registries ensure compliance with FDA requirements for medical devices, categorizing their products based on risk levels and regulatory pathways.

Technolas GmbH Perfect Vision’s devices are classified under FDA regulations as Class I, Class II, or Class III, depending on their risk level and intended use. Class I devices generally pose the lowest risk (e.g., some disposable blades), while Class II and Class III devices (like femtosecond laser systems or excimer lasers) require stricter controls due to higher risks. Classification determines the regulatory pathway, such as PMA for higher-risk devices or UDI compliance for others.