Epcon Laboratories
Country not established
- Devices
- 1
What Epcon Laboratories makes
Epcon Laboratories manufactures intraocular lenses (IOLs), including spherical and toric versions of their Polymacon material, designed for cataract surgery and corneal refractive correction. These lenses are intended for implantation in the eye to restore vision clarity and address astigmatism. The product line focuses on providing optical solutions for patients requiring permanent lens replacement.
The company’s devices are classified as Class II under FDA regulations and are authorised through the Premarket Approval (PMA) pathway. These products are listed in the FDA’s regulatory database, adhering to US medical device compliance standards. The manufacturer operates from the United States.
Catalogue
- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Epcon Laboratories have in the registry?
The registry currently lists 1 device for Epcon Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epcon Laboratories's devices?
Among its 1 most recently registered device, Epcon Laboratories has devices listed in FDA PMA (1 device).
What risk classes do Epcon Laboratories's devices fall under?
Among its 1 most recently registered device, the classes recorded for Epcon Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Epcon Laboratories in the registry?
The most recently registered devices listed for Epcon Laboratories include EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES.