Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
The Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (PMMA) (product code NYK) is a diagnostic ophthalmic device applied directly to the globe or cornea for examination of the ocular fundus, vitreous, and retinal structures, while simultaneously measuring and displaying the amount of force applied to the eye. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 886.1385 within the Ophthalmic specialty. The device carries no implant or life-sustaining flags.
Basic Information
- Product Code
- NYK
- Device Class
- FDA class 2
- Regulation Number
- 886.1385
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K052674 | CONTACT LENS OPHTHALMODYNAMOMETER | May 24, 2006 | Substantially Equivalent | MEDITRON, GMBH |