Refractec, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Refractec, Inc. makes
Refractec, Inc. manufactures ophthalmic surgical tools, including the REFRACTEC MCS-100 for corneal measurement, the OPTIPOINT Corneal Marker (Model VPT-OPT-450) for marking corneal incisions, and the VIEWPOINT CK System’s keratoplasty tip component for precision corneal transplantation procedures.
The company’s devices are regulated under FDA pathways, with some classified as Class I, others as Class II, and a few as Class III. They appear in the FDA’s 510(k) and PMA registries, indicating premarket submissions for authorisation. The manufacturer is based in the United States.
Catalogue
Refractec Mcs-100 Ref K980522
Regimes: 510(k) Registry: 510(k)Optipoint Corneal Marker, Model Vpt-Opt-450 Ref K053475
Regimes: 510(k) Registry: 510(k)Viewpoint Ck System (Keratoplast Tip Component) Ref P010018
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Refractec, Inc. have in the registry?
The registry currently lists 3 devices for Refractec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Refractec, Inc.'s devices?
Among its 3 most recently registered devices, Refractec, Inc. has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Refractec, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Refractec, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Refractec, Inc. in the registry?
The most recently registered devices listed for Refractec, Inc. include REFRACTEC MCS-100, OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 and VIEWPOINT CK SYSTEM (KERATOPLAST TIP COMPONENT).