NYK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1385
- Medical specialty
- Ophthalmic
- FDA definition
- Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CONTACT LENS OPHTHALMODYNAMOMETER (K052674) | Meditron, GmbH | 2006-05-24 |
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