REVISION OPTICS, INC.

Revision Optics, Inc. specializes in two primary categories of ophthalmic devices: corneal inlays that reduce the aperture size for near vision correction, such as the Raindrop Near Vision Inlay, and manual ophthalmic surgical instrument handles, like the Inlay Inserter Chuck Handle. These devices are designed to assist in vision correction procedures and surgical precision.

Revision Optics, Inc. is headquartered in the United States. Since it operates within the U.S., its devices are subject to FDA regulations, including classification under the FDA’s device classification system. This means compliance with U.S. regulatory requirements is a key consideration for the company’s products.

Devices produced by Revision Optics, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices under FDA oversight, ensuring traceability and compliance with regulatory requirements.

All devices manufactured by Revision Optics, Inc. fall under Class III classification according to FDA regulations. This classification applies to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices require premarket approval (PMA) or are exempt from PMA but still subject to strict regulatory controls.