Alcon
Country not established
- Devices
- 9
What Alcon makes
Alcon manufactures ophthalmic devices including intraocular lenses (IOLs), such as zirconia silicate bead IOL tumble polishing systems and specific models like 1S, 1P, and AC (AC1–AC5), as well as contact lens care solutions like the Opti-Free Express multi-purpose solution and Silikon 1000. Their portfolio also includes components for surgical vision systems, such as the Alcon Vision System.
The company’s devices are regulated under FDA pathways, with Class II and Class III products authorised via 510(k) clearances and Premarket Approval (PMA) applications. These products are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
Alcon Vision System Ref K063583
Regimes: 510(k) Registry: 510(k)Opti-Free Express Multi-Purpose Solution Ref K981574
Regimes: 510(k) Registry: 510(k)Inteliport Occluding Device Ref K040231
Regimes: 510(k) Registry: 510(k)Soft (Hydrophilic) Contact Lens Care Solution Ref K031193
Regimes: 510(k) Registry: 510(k)Alcon Multi-Purpose Solution Ref K071236
Regimes: 510(k) Registry: 510(k)Models 1S & 1P Ref P800049
Regimes: PMA Registry: PMAZirconia Silicate Bead IOL Tumble Polishing Ref P820035
Regimes: PMA, withdrawn Registry: PMAModel Ac (AC1-AC5) Ref P810001
Regimes: PMA Registry: PMASilikon 1000 Ref P950008
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Alcon have in the registry?
The registry currently lists 9 devices for Alcon. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alcon's devices?
Among its 9 most recently registered devices, Alcon has devices listed in FDA 510(k) (5 devices) and FDA PMA (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Alcon's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Alcon's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Alcon in the registry?
The most recently registered devices listed for Alcon include ALCON VISION SYSTEM, OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION, INTELIPORT OCCLUDING DEVICE and SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION.