Quality Sunglasses, Ltd.

Quality Sunglasses, Ltd. specializes in prescription and non-prescription sunglasses, including those with polarized lenses and various tints. These products are designed primarily for UV protection and general eyewear use, falling under the category of medical devices due to their intended purpose of safeguarding eye health.

The company is headquartered in the United States. This location is relevant for regulatory compliance, as the FDA oversees the classification and clearance of its devices under U.S. jurisdiction.

Quality Sunglasses, Ltd.’s products are classified as Class I medical devices by the FDA. This classification applies because the devices are considered low-risk, with minimal potential for harm when used as intended. Class I devices typically require general controls (e.g., good manufacturing practices) but do not require a 510(k) pre-market notification unless they are modified or present new risks. However, the company’s devices are listed in the FDA’s 510(k) database, indicating they may have undergone a clearance process for specific variations or features.

Quality Sunglasses, Ltd.’s devices are included in the FDA’s 510(k) database. This registry tracks medical devices that have received 510(k) clearance (if applicable) or are otherwise subject to FDA oversight. Listing here helps ensure transparency and allows healthcare providers, regulators, and consumers to verify compliance and device details.