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LenSx Lasers Inc. announced that the FDA has granted 510(k) clearance for its femtosecond laser used for anterior capsulotomy during cataract surgery.
Aliso Viejo, CA
-LenSx Lasers Inc. announced that the FDA has granted 510(k) clearance for its femtosecond laser used for anterior capsulotomy during cataract surgery.
Initial clinical evaluation, conducted by Zoltan Nagy, MD, PhD, of Semmelweis University in Budapest, Hungary, has shown that when compared with that of a manually created capsulorhexis, the achieved diameter of a laser capsulotomy was significantly more uniform and reproducible, according to a prepared statement. The intended diameter was achieved in 100% of capsulotomies performed with the proprietary femtosecond laser, whereas diameter accuracy of ± 0.25 mm was observed in 10% of manual procedures.
“While current cataract surgery techniques can achieve excellent outcomes, the procedure still relies on multiple manual steps,” said Stephen G. Slade, MD, medical director, LenSx. “The . . . femtosecond laser has been designed to advance the precision and reproducibility of key portions of the procedure, something we have seen lasers do repeatedly in other ophthalmic procedures.”