BUSINESS WIRE
ORLANDO, Fla.--(BUSINESS WIRE)--LensAR, Inc., the leading developer of next-generation laser technology
for refractive cataract surgery, announced today that the company has
received 510(k) clearance from the FDA for use of the LensAR™ Laser
System 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. We are very pleased with the exceptional
fragmentation data that was submitted to obtain the indication and the
resulting FDA clearance,” said Randy Frey, founder and Chief Executive
Officer of LensAR™.
Louis “Skip” Nichamin, MD, went on to comment, “In 2010, I was honored
to be the first US surgeon to use the LensAR™ Laser System. I found that
even in the most advanced grades of cataract that the lens fragmentation
and extraction process was considerably more proficient and seamless
than conventional phacoemulsification. The recent FDA clearance is a
tremendous accomplishment in advancing innovative technologies that will
improve lens replacement surgery.”
The LensAR™ Laser System has been developed to meet the advancing needs
of refractive cataract surgeons and their patients. The proprietary
3D-CSI™ (Confocal Structured Illumination) imaging and biometry system
is being designed to image and analyze the anatomy across all grades of
cataract to improve proficiency.
Unlike traditional imaging systems, 3D-CSI™ provides clean, low noise
images that are both high contrast and high-resolution from the anterior
surface of the cornea to the posterior capsule. The precision of the
LensAR™ Laser System creates an exact capsulotomy incision size and
placement based on IOL selection and fragments high grade cataracts for
easier removal.
The LensAR™ Laser System is cleared by the FDA for anterior capsulotomy
and lens fragmentation. The system has been used in more than 500 eyes
outside the United States to date. For other indications it is an
investigational device limited by US law to investigational use only.
About LensAR
LensAR, Inc., is the leader in the development and commercialization of
the next-generation laser and advanced 3D imaging technology for
refractive cataract surgery. For more information, please visit www.lensar.com.