Alcon, Inc. is one of 21645 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Alcon, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ALCON MULTI-PURPOSE SOLUTION, INTELIPORT OCCLUDING DEVICE, SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
3
Total
3
Cleared
0
Denied
Alcon, Inc. is the global leader in eye care, dedicated to helping people see brilliantly. With a heritage spanning over 75 years, the company operates as the largest eye care device manufacturer worldwide. Alcon maintains a manufacturing facility in Fort Worth, Texas, and serves patients across more than 140 countries through operations in 60 nations.
Alcon's FDA 510(k) regulatory record includes 3 cleared devices from 3 total submissions, spanning 2003 to 2007. The company specializes exclusively in Ophthalmic devices, reflecting its core focus on vision care solutions. This historical record demonstrates the company's established presence in FDA-regulated eye care device development.
Alcon's cleared device portfolio encompasses contact lens care solutions, occluding devices, and multi-purpose ophthalmic products. The company pioneered numerous industry firsts, including the DROPTAINER® eye drop dispensing bottle and advanced intraocular lens technologies. Notable innovations include AcrySof® IQ lenses, SYSTANE® dry eye treatments, and silicone hydrogel contact lens platforms.
Explore the complete regulatory history by reviewing individual device names, product codes, and FDA 510(k) clearance dates in the database.
FDA 510(k) Regulatory Record - Alcon, Inc.
3 devices