Article

Hyperopia clinical module submitted to FDA

Fremont, CA-Nidek Inc. has submitted its hyperopia PMA clinical module to the FDA for review and approval of its EC-5000 Excimer Laser System for hyperopia, hyperopic astigmatism, and mixed astigmatism. This marks the final step in gaining commercialization approval by the FDA to market and treat indications of hyperopia with the Nidek system.

Related Videos
(Image credit: Ophthalmology Times) NeuroOp Guru: Cranial nerve six palsy with chemosis is a critical clue to cavernous carotid fistula
(Image credit: Ophthalmology Times) Neda Shamie_Controversies in Modern Eye Care 2025
(Image credit: Ophthalmology Times) World Cornea Congress IX: Epi-on and accelerated crosslinking with Kenneth Beckman, MD
(Image credit: Ophthalmology Times) The synergy of cornea, cataract, and refractive surgery through the decades: insights from George O. Waring IV, MD
(Image credit: Ophthalmology Times) AGS 2025: A look at Gemini and the MIGS revolution with Mona Kaleem, MD
(Image credit: Ophthalmology Times) AGS 2025: Development and evaluation of an AI model to set target IOP with Jithin Yohannan, MD, MPH
© 2025 MJH Life Sciences

All rights reserved.