ORLANDO, Fla.--(BUSINESS WIRE)--LENSAR Inc., developer of the LENSAR Laser System™ for cataract surgery, today provided an update on the company’s recent regulatory and commercialization efforts for its novel laser cataract surgery system. The LENSAR Laser System represents the latest scientific breakthrough in cataract surgery, combining the most advanced laser technology with unique product features specifically intended to meet the advancing needs of refractive cataract surgeons to enhance their patients’ outcomes. Recent developments include: Regulatory: In recent months, LENSAR has received 510(k) clearance from the United States Food and Drug Administration and CE Mark approval from European regulators for the LENSAR Laser System. Both regulatory actions, which cover the use of the novel platform in capsulotomy with and without laser phacofragmentation during cataract surgery, have opened the door for strategic and aggressive commercialization efforts in these markets.
