Optonol, Ltd.
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Optonol, Ltd. makes
Optonol, Ltd. manufactures glaucoma drainage implants, including the EX-PRESS Miniature Glaucoma Implant (models R-20, R-30, R-50, and STS versions) and the EXPRESS Mini Glaucoma Shunt. These devices are designed to reduce intraocular pressure in patients with glaucoma by providing alternative drainage pathways for aqueous humor.
The company’s portfolio is regulated under FDA Class II medical devices, with devices listed via the 510(k) clearance pathway. The products are intended for use in the United States, where Optonol, Ltd. is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Express Mini Glaucoma Shunt Ref K030350
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Optonol, Ltd NEVE ILAN Central · IL FEI 3003701944
Frequently asked questions
How many devices does Optonol, Ltd. have in the registry?
The registry currently lists 2 devices for Optonol, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optonol, Ltd.'s devices?
Among its 2 most recently registered devices, Optonol, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Optonol, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Optonol, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optonol, Ltd. in the registry?
The most recently registered devices listed for Optonol, Ltd. include EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS and EXPRESS MINI GLAUCOMA SHUNT.
Which FDA establishments are linked to Optonol, Ltd.?
1 FDA establishment is linked to Optonol, Ltd. in the registry; they are listed on the company page.