Laser system gets 510(k) clearance

March 30, 2011

The FDA granted 510(k) clearance March 16 to a laser system (LensAR Laser System, LensAR Inc.) for anterior capsulotomy and lens fragmentation during cataract surgery.

Silver Spring, MD-The FDA granted 510(k) clearance March 16 to a laser system (LensAR Laser System, LensAR Inc.) for anterior capsulotomy and lens fragmentation during cataract surgery.

“Receiving the additional FDA indication for lens fragmentation is a significant milestone achievement in getting our technology one step closer to commercialization,” said Randy Frey, founder and chief executive officer of LensAR.

The system includes a proprietary imaging and biometry system (3-D CSI, which stands for three-dimensional confocal structured illumination) for imaging and analysis of the anatomy across all grades of cataract, to improve proficiency. The imaging and biometry system is designed to provide clean, low-noise images that are both high contrast and high resolution from the anterior surface of the cornea to the posterior capsule. The laser’s precision helps with capsulotomy incision size and placement based on IOL selection and fragments high-grade cataracts for easier removal, according to the company.

The system has been used in more than 500 eyes outside the United States to date. For indications other than anterior capsulotomy and lens fragmentation during cataract surgery in the United States, the system is an investigational device.