Sensor Medical Technology, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Sensor Medical Technology, LLC makes
Sensor Medical Technology, LLC manufactures vitrectomy lenses and related products for ophthalmic surgery, including single-use tonometer prisms and disposable lens systems designed for intraocular procedures. Their portfolio includes tools used during vitrectomy, a minimally invasive surgery to remove the vitreous gel from the eye, as well as accessories for intraocular pressure measurement. The company also supplies reusable and disposable lens options for surgical applications.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. Vitrectomy lenses and related surgical tools fall under Class II due to their role in critical procedures, while other accessories may qualify as Class I. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory clearance status in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Sensor Medical Single Use Tonometer Prism Ref K152308
Regimes: 510(k) Registry: 510(k)Family Of Disposable Lenses Ref K140368
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sensor Medical Technology, LLC have in the registry?
The registry currently lists 3 devices for Sensor Medical Technology, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sensor Medical Technology, LLC's devices?
Among its 3 most recently registered devices, Sensor Medical Technology, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Sensor Medical Technology, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sensor Medical Technology, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sensor Medical Technology, LLC in the registry?
The most recently registered devices listed for Sensor Medical Technology, LLC include Sensor Medical Family of Vitrectomy Lenses and Products, Sensor Medical Single Use Tonometer Prism and FAMILY OF DISPOSABLE LENSES.