NYK · Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
Ophthalmic · 21 CFR 886.1385 · Class 2
Overview
| Product Code | NYK |
|---|---|
| Device Name | Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma) |
| Regulation | 21 CFR 886.1385 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052674 | CONTACT LENS OPHTHALMODYNAMOMETER | Meditron, GmbH | May 24, 2006 | SESE |
Top Applicants
- Meditron, GmbH — 1 clearance
