# Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
> **Product code: NYK** · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1385
## Classification
- **FDA Product Code:** NYK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 886.1385
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NYK)
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