Action Eyewear Corp.

Action Eyewear Corp. specializes in protective medical devices for healthcare and dental settings. Their portfolio includes single-use or limited-use products like the ACTION MEDTEK Face Shield and ACTION MEDTEK/DENTEK Eyeglasses, designed to minimize contamination risk during procedures. These devices are intended for use in environments where infection control is critical.

Action Eyewear Corp. is headquartered in the United States. The company’s focus on manufacturing medical-grade protective eyewear and face shields aligns with U.S. regulatory standards, ensuring compliance with local healthcare requirements.

Action Eyewear Corp.’s devices fall under the FDA’s Class I classification, which includes the lowest-risk medical products. This classification is determined by the FDA based on the intended use and risk profile of the devices, such as the ACTION MEDTEK Face Shield and ACTION MEDTEK/DENTEK Eyeglasses. Class I devices typically undergo general controls and may require premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device.

Action Eyewear Corp.’s devices are registered in the FDA’s 510(k) premarket notification database. This pathway is used to demonstrate that a new device is at least as safe and effective as a legally marketed predicate device. Listing in this registry ensures transparency and compliance with U.S. medical device regulations.

Action Eyewear Corp.’s single-use or limited-use devices, such as the ACTION MEDTEK Face Shield and ACTION MEDTEK/DENTEK Eyeglasses, are engineered to reduce contamination risks in medical and dental environments. Single-use products minimize the risk of cross-contamination between patients, aligning with infection control best practices in healthcare settings. This design choice also simplifies sterilization processes, as disposable or short-term-use items avoid the need for repeated cleaning or reprocessing.