Freedom Meditech has submitted a premarket notification 510(k) application to the US Food and Drug administration (FDA) for its ClearPath DS-120 Lens Fluorescence Biomicroscope.
The ClearPath DS-120 uses proprietary fluorescence spectroscopy to identify patients with signs of degenerative changes in the lens of the eye.
The degenerative changes with other data collected in a routine health examination can aid clinician to diagnose diseases that affect the structural properties of the lens and can also evaluate both the potential risk of chronic systemic disease and the need to institute appropriate patient management plans.
The application included the performance data from a clinical trial that was both approved for conduct by a third-party institutional review board and managed by an independent contract research organization.
The company also received independent third-party reviews, reports and certifications for software validation and verification, eye safety optical radiation hazard analysis and electromagnetic safety, immunity and compatibility.
Freedom Meditech chairman and CEO Craig Misrach said they look forward to work with the FDA in order to bring this product to market.
The company intends to pursue CE mark for its device.