Alcon is one of 8301 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Alcon - FDA 510(k) Cleared Devices
Recent clearances: OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
2
Total
2
Cleared
0
Denied
Alcon, is the global leader in eye care, dedicated to helping people see brilliantly. With over 75 years of heritage, the company operates as the largest eye care device manufacturer worldwide. Alcon maintains a manufacturing facility in Fort Worth, Texas, and serves patients in more than 140 countries across 60 global markets.
Alcon has received 2 FDA 510(k) clearances from 2 total submissions, with all submissions focused on Ophthalmic devices. The company's regulatory clearance history spans from 1998 to 2008. This represents a historical record of FDA regulatory activity; no new clearances have been submitted in recent years.
Alcon's cleared device portfolio includes surgical vision systems and multi-purpose contact lens care solutions. The company has a documented history of industry firsts in Ophthalmic innovation, including pioneering intraocular lenses, silicone hydrogel contact lenses, and advanced surgical platforms. Substantial annual investment in research and development has supported the company's position in eye care technology.
Explore the complete regulatory record, including specific device names, product codes, and individual clearance dates in the database.
FDA 510(k) Regulatory Record - Alcon
2 devices