Oculus receives premarket approval for PARK 1 diagnostic system
The U.S. Food and Drug Administration has granted premarket approval to Oculus for its PARK 1 diagnostic system for photographing and measuring the eye, the company announced in a press release.
Designed to photograph the anterior segment, evaluate corneal thickness and measure refractive power, the PARK 1 (Pachymeter/Auto-Refractor/Keratometer) is the first platform that combines an autorefractometer with a Scheimpflug-based non-contact pachymeter, the release said.
Featuring a 5.7" LCD screen display, the intuitive alignment system allows for quick and reliable measurements in three separate modes: pachymetry alone, a combination of autorefractometry and keratometry, or a combination of pachymetry, autorefractometry and keratometry. In addition, the platform's small footprint and external power supply can be mounted on refraction units and height adjustable tables, and the implanted patient data management system can connect to office software, according to company literature.
Oculus plans to launch PARK 1 at the American Academy of Ophthalmology meeting in Atlanta.