Ocutec Corporation, Inc.
Country not established
- Devices
- 2
What Ocutec Corporation, Inc. makes
Ocutec Corporation, Inc. manufactures laser-based ophthalmic devices, including the NOVALENS system for corneal refractive procedures and the NOVALENS (ROSILFOCON A) for specific vision correction applications. These devices use laser technology to reshape the cornea, targeting conditions such as myopia, hyperopia, and astigmatism.
The company’s products are regulated as Class II medical devices in the US, with authorisation through FDA pathways including 510(k) and PMA clearances. These devices are listed in the FDA’s regulatory records, and the manufacturer is based in the United States.
Catalogue
Novalens/Novawet Perception And Vanguard Ref K942533
Regimes: 510(k) Registry: 510(k)Novalens (Rosilfocon A) Ref P890058
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Ocutec Corporation, Inc. have in the registry?
The registry currently lists 2 devices for Ocutec Corporation, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ocutec Corporation, Inc.'s devices?
Among its 2 most recently registered devices, Ocutec Corporation, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ocutec Corporation, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ocutec Corporation, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ocutec Corporation, Inc. in the registry?
The most recently registered devices listed for Ocutec Corporation, Inc. include NOVALENS/NOVAWET PERCEPTION AND VANGUARD and NOVALENS (ROSILFOCON A).