LENSAR adds second FDA approval

Key Points

Orlando, FL-On March 16, LensAR Inc. received 510(k) clearance from the FDA to market its femtosecond laser system (LensAR Laser System) for lens fragmentation in addition to anterior capsulotomy during cataract surgery.

"Results of studies conducted with the LensAR system demonstrate that it provides a very effective, efficient, and reproducible means for disassembling the nucleus as well as for creating a precisely sized and placed capsulotomy, and laboratory work is now under way to develop the instrument for use in creating corneal incisions," Dr. Nichamin said.

Randy W. Frey, founder and chief executive officer of LensAR, said, "We are thrilled about the two clearances, originally anterior capsulotomy, and now for use of our system to perform anterior capsulotomy and lens fragmentation during cataract surgery.

"We are especially excited about the indication for lens fragmentation because our data show the LensAR platform is extremely effective in fragmenting high-grade cataracts," Frey added. "As David Chang, MD, says, 'Those are the ones that surgeons need the most help on.'

"We also believe our platform has [a] unique measurement technology in the industry as it provides the cleanest, high-definition images for the software to process and automatically guide placement of cuts where they are required," Frey continued. "Now, we are developing the LensAR system for creating clear corneal and limbal relaxing incisions, which we believe is an essential indication in the business model. Delivering these capabilities to surgeons is our next focus."