Insight Technologies Instruments, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Insight Technologies Instruments, LLC makes
Insight Technologies Instruments, LLC manufactures keratome systems, including the Model K3000, which are used for precise corneal cutting in ophthalmic procedures.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Keratome System Ref K974243
Regimes: 510(k) Registry: 510(k)Keratome System, Model K3000 Ref K984537
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Insight Technologies Instruments, LLC have in the registry?
The registry currently lists 2 devices for Insight Technologies Instruments, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Insight Technologies Instruments, LLC's devices?
Among its 2 most recently registered devices, Insight Technologies Instruments, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Insight Technologies Instruments, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Insight Technologies Instruments, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Insight Technologies Instruments, LLC in the registry?
The most recently registered devices listed for Insight Technologies Instruments, LLC include KERATOME SYSTEM and KERATOME SYSTEM, MODEL K3000.