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
| Device Type ID | 4394 |
| Device Name | Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (pmma) |
| Physical State | The Contact Lens Consists Of A Curved Shell Of Acrylic Plastic (PMMA), Which Is Adapted With Electronic Sensors For Measurement Of Pressure Applied To The Eye. The Pressure Values Are Displayed On A LCD Display. |
| Technical Method | The Examination PMMA Contact Lens Is Adapted With Electronic Sensors For Measurement Of Pressure Applied To The Eye. The Pressure Values Are Displayed On A LCD Display. |
| Target Area | Eye |
| Regulation Description | Polymethylmethacrylate (PMMA) Diagnostic Contact Lens. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.1385 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NYK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4394 |
| Device | Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (pmma) |
| Product Code | NYK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polymethylmethacrylate (PMMA) Diagnostic Contact Lens. |
| CFR Regulation Number | 886.1385 [🔎] |