NYK — Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma) Class II
FDA product code NYK covers "Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)", a Class II medical device regulated under 21 CFR 886.1385. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NYK
- Device Class
- Class II
- Regulation Number
- 886.1385
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052674 | meditron | CONTACT LENS OPHTHALMODYNAMOMETER | May 24, 2006 |