The FDA OKs LensAR's laser system for executing corneal incisions, giving the system full indications for all the critical components of laser cataract surgery.
Orlando, Fla.-based LensAR won additional FDA clearance for its next-generation LensAR laser system, gaining indication for performing corneal incisions during cataract surgery.
With the latest regulatory win the LensAR system is cleared for all critical aspects of laser cataract surgery, including lens fragmentation, anterior capsulotomy and corneal incisions, according to the press release.
"We are pleased with this latest broadening of the cleared indications for the LensAR system as it demonstrates the continued ability of the LensAR team to establish strategic development and commercialization objectives and then systematically deliver on those goals," CEO Nick Curtis said in prepared remarks. "At the same time, the continued expansion of FDA-cleared indications provides significant value to the cataract surgeon community and we expect this important regulatory milestone to add to the steadily increasing demand for our system worldwide."
The system features sophisticated phacofragmentation techniques and allows physicians to perform procedures with less or no ultrasound energy, according to a press release.
The company said an entire laser cataract treatment could take place in a single procedure room and the mobile LensAR system can adapt to existing surgical facilities.
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