Yes. iScreen Vision, a photoscreener, was cleared to begin marketing by the FDA through the 510(k) process under a classification as ophthalmic camera. Products under this classification are Class II devices and are required to demonstrate their safety and efficacy to the FDA as part of the 510(k) process. The FDA identifies an ophthalmic camera as “an AC-powered device intended to take photographs of the eye and the surrounding area.”
Some ophthalmic devices, such as autorefractors (also known as auto-refractors or auto refractors or hand held or portable autorefractors) classify themselves as ophthalmic refractometers –– and are Class I devices. The FDA identifies ophthalmic refractometers as “an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.”Ophthalmic refractometers are exempt from FDA premarket notification procedures and are not subject to the same level of regulatory control by the FDA.
According to the FDA, “Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device. Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness.” (Source:http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm)