The Korean Food and Drug Administration (KFDA) has approved an intracorneal inlay (Kamra, AcuFocus) for presbyopia.
Irvine, CA-The Korean Food and Drug Administration (KFDA) has approved an intracorneal inlay (Kamra, AcuFocus) for presbyopia.
“We are extremely thrilled to be able to offer this advanced vision correction technology in Korea,” said Ed Peterson, AcuFocus president and chief executive officer. “The approval from the KFDA is a testament to the excellent global results achieved with the device.”
The device offers an alternative to reading glasses, contact lenses, and monovision LASIK. It is designed to create a small-aperture effect, allowing the eye to see near and intermediate objects more clearly while maintaining distance vision. By applying the “depth-of-focus” principle commonly used in photography, the inlay controls light transmission, allowing only central rays to reach the retina through a fixed, 1.6-mm aperture.
“We are confident that the Korean market will be eager to take advantage of this advanced treatment option, and we are excited to facilitate that process,” said In-Bum Choi, chief executive officer of Woo Jeon Medical, which distributes the inlay in Korea.
The device is considered an investigational device in the United States and has received CE mark for use in the European Union. To date, it has been implanted in more than 11,000 patients and is available in 35 countries in Europe, Asia, the Middle East, and South America.
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