OCULUS Optikgeräte GmbH

OCULUS Optikgeräte GmbH specializes in ophthalmic diagnostic and examination tools. Their product range includes coated trial lenses (such as cylindrical lenses and lens sets) for refraction testing, lid sticks for eyelid assessment, adjustable examination tables (Hubtisch), digital imaging devices like the ImageCam 3, visual acuity charts for children (e.g., Löhlein-style picture charts), and specialized testing instruments such as the Mesotest II for evaluating the ocular surface. These devices support clinical assessments in ophthalmology, optometry, and opticianry.

OCULUS Optikgeräte GmbH is based in Germany, which means its devices are subject to the European Union’s Medical Device Regulations (MDR). The company’s products are listed in the EU’s eudamed database, indicating compliance with EU regulatory requirements. Additionally, some of their devices are also included in the FDA’s 510(k) registry, reflecting their market presence in the United States under FDA oversight.

OCULUS’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIa. Classification determines the regulatory pathway and risk level: Class I devices are generally low-risk (e.g., simple examination tools), while Class IIa devices involve moderate risks (e.g., certain diagnostic tools). This classification influences manufacturing standards, post-market surveillance requirements, and technical documentation needed for compliance, ensuring patient safety and device performance.

OCULUS’s devices are listed in two key regulatory databases: the EU’s eudamed system, which tracks medical devices authorized under EU regulations, and the FDA’s 510(k) registry, which documents devices cleared for the U.S. market. These listings provide transparency on device types, classifications, and regulatory status, helping stakeholders verify compliance and traceability.

The FDA’s 510(k) registry includes OCULUS devices that have undergone the U.S. premarket notification process to demonstrate substantial equivalence to a predicate device. While the exact devices aren’t specified here, the registry would typically feature diagnostic tools like trial lenses, imaging devices (e.g., ImageCam 3), or other ophthalmic examination instruments that meet FDA’s requirements for market clearance in the U.S. The inclusion reflects compliance with FDA’s regulatory framework for these specific products.