Medical Device Manufacturer · US , Fort Worth , TX

Alcon Laboratories, Inc. - FDA 510(k) Cleared Devices

43 submissions · 42 cleared · Since 1996
43
Total
42
Cleared
0
Denied

Alcon Laboratories, Inc. is an eye care company headquartered in Fort Worth, Texas. The company develops innovative vision products and treatments for patients worldwide.

Alcon maintains a strong FDA 510(k) regulatory record with 42 FDA 510(k) cleared devices from 43 total submissions. The company specializes exclusively in Ophthalmic devices, a focus reflected across its entire submission portfolio. Alcon's regulatory activity spans from 1996 to 2026, with recent clearances demonstrating continued innovation in vision care technologies.

Recent FDA 510(k) clearances include contact lenses, laser surgical systems, and vitreoretinal surgical instruments. These devices support cataract surgery, refractive procedures, and general ophthalmic care. The company's product portfolio reflects deep expertise in both surgical and vision correction technologies.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Alcon / Ciba Vision GmbH as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Alcon Laboratories, Inc.
43 devices
1-12 of 43

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