Clic Goggles Inc.

Clic Goggles Inc. specializes in prescription spectacles, which are medical devices used for vision correction. Their product line includes single-vision, bifocal, and progressive lenses, catering to both adults and children. These devices are designed to address refractive errors and may incorporate additional features like anti-reflective coatings or blue-light filtering to enhance comfort and usability.

Clic Goggles Inc. is based in the United States. While the company’s location influences its regulatory compliance framework—such as adherence to FDA standards—the specific type of device it manufactures (prescription spectacles) determines its classification and oversight. The company’s devices fall under FDA jurisdiction, ensuring they meet applicable safety and performance requirements for medical eyewear.

Clic Goggles Inc.’s prescription spectacles are classified as Class I devices under FDA regulations. This classification applies because these devices pose minimal risk to users and are generally considered safe and effective for their intended purpose—vision correction—without requiring stringent pre-market approval. Class I devices typically undergo general controls, including registration, listing, and adherence to good manufacturing practices.

Yes, Clic Goggles Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain by assigning a unique identifier to each distinct device. This helps regulators, healthcare providers, and patients verify product authenticity and compliance with FDA requirements.