Basic Information
- Primary DI
- 17290016352228
- Basic UDI-DI Code
- B-17290016352228
- Reference
- KIT-003-EU
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- EyeYon Medical Ltd.
Additional Description
The Hyper-CLโข therapeutic contact lens integrates an innovative design featuring two main base curves, a groove and fenestrations. The fenestrations increase tear film exchange between the cornea and the contact lens and enable entry of the instilled drops into the groove and lens reservoir. The internal groove connected to the anterior surface via fenestrations, acts as a reservoir in addition to the central reservoir, both of which create a cavity between the lens and the cornea that retains any applied eye drop for a prolonged period of time, enhancing its effectiveness. In this manner, they increase the accessibility and overall contact time of ophthalmic solutions (drops) with the center of the cornea, as well as increase oxygen permeability.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q021004010102 | CONTACT LENSES - HYDROGEL, EXTENDED SINGLE-USE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 7406GB410210510A | DNV MEDCERT GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).