Eyoto, Inc.

Eyoto, Inc. specializes in automated lensmeters, such as the Atlas model. These devices are designed to measure key optical parameters of eyeglass lenses with high accuracy and efficiency, streamlining the process for opticians and eye care professionals.

Eyoto, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in the context of FDA compliance and market distribution.

Eyoto, Inc.’s devices, including the Atlas automated lensmeter, fall under Class I classification according to FDA regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, such as certain optical instruments. The classification influences the regulatory pathway for authorization.

Yes, Eyoto, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency in the supply chain, which is critical for tracking devices post-market and complying with FDA requirements for medical device identification.