Oculab, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Oculab, Inc. makes
Oculab, Inc. manufactures disposable and reusable ophthalmic measurement tools, including protective tip covers for ocular probes, handheld biometric and tonometric devices for eye examinations, and surgical drapes for intraocular procedures. Their portfolio also includes calculators for pachymetry and intraocular lens power planning, as well as pen-style instruments for corneal thickness and pressure measurements.
The company’s devices are regulated under FDA Class II and Class III classifications, with several authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Ocu-Film Tip Cover Ref K882750
Regimes: 510(k) Registry: 510(k)Oculab Biometricpen Ref K860061
Regimes: 510(k) Registry: 510(k)Oculab Tonopen Ref K852774
Regimes: 510(k) Registry: 510(k)Pach-Pen Calculator Ref K884619
Regimes: 510(k) Registry: 510(k)Bio-Pen Calculator Ref K860205
Regimes: 510(k) Registry: 510(k)Pach-Pen Surgical Drape Ref K862016
Regimes: 510(k) Registry: 510(k)Oculab Pachpen Ref K860062
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oculab, Inc. have in the registry?
The registry currently lists 7 devices for Oculab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oculab, Inc.'s devices?
Among its 7 most recently registered devices, Oculab, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Oculab, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Oculab, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Oculab, Inc. in the registry?
The most recently registered devices listed for Oculab, Inc. include OCU-FILM TIP COVER, OCULAB BIOMETRICPEN, OCULAB TONOPEN and PACH-PEN CALCULATOR.