Topcon Receives FDA 510(k) Clearance and Launches OMNIA, a Fully Automated 4-in-1 Pretesting System

Topcon Healthcare has received FDA 510(k) clearance and announced the U.S. launch of OMNIA, a fully automated 4-in-1 pretesting device developed to support efficiency and consistency in clinical workflows.

The compact system combines objective refraction, keratometry, tonometry, and pachymetry into a single platform, allowing eye-care professionals to obtain consistent measurements with limited operator training.

“Healthcare from the Eye starts with consistent, high-quality data,” said Ali Tafreshi, CEO and President of Topcon Healthcare, Inc. “OMNIA delivers fast, reliable measurements that reduce data collection time, enhance clinical precision, and give practitioners more time to connect with their patients.”

Integrated System for Streamlined Pretesting

Designed for clinics, surgical centers, and high-volume practices, OMNIA consolidates four essential pretests into one instrument. The system is intended to reduce testing time, patient waiting periods, and overall equipment footprint within the clinic.

It features a 360-degree rotating touchscreen for flexible setup and easier patient positioning. The system’s DICOM compatibility allows integration with electronic medical record (EMR) systems and digital practice management tools.

“OMNIA gives practices exactly what they’ve been asking for—fast, consistent measurements that streamline the entire pretest workflow,” said Lance Patton, Chief Commercial Officer at Topcon Healthcare, Inc. “By combining four critical tests in one device, we’re helping clinics reduce bottlenecks, shorten chair time, and elevate the patient experience.”

Technical Features and Measurement Capabilities

OMNIA includes several proprietary technologies to improve accuracy and comfort. Topcon’s Advanced Rotary Prism Technology is designed to minimize fundus-related artifacts, providing more consistent measurements.

A super luminescent diode (SLD) light source offers enhanced image brightness compared to traditional LED systems, supporting accuracy even in eyes with media opacities such as cataracts. The system also employs a quieter and softer air puff during tonometry to improve patient comfort.

Automation and Customization Options

OMNIA is equipped with fully automated data capture and a one-touch user interface, allowing easy operation for both experienced and new users. Clinicians can customize testing sequences, choosing among objective refraction, keratometry, tonometry, or pachymetry, depending on clinical preference.

An optional manual mode provides additional control for complex or specialized cases.