Definition: A Diurnal Pattern Recorder System Is A Non-implantable, Prescription Device Incorporating A Telemetric Sensor Intended To Detect Changes In Ocular Dimension For Monitoring Diurnal Patterns Of IOP Fluctuation.
| Device Type ID | 4407 |
| Device Name | Ocular Pattern Recorder |
| Physical State | Hydrophillic Lens With Active Strain Gauge. RF Receiving Antenna Connected To A Recorder To Track Data Over Time. Unit Also Includes Dedicated Software Package To Review Recorded Device |
| Technical Method | The Device Is Comprise Of A Hydrophilic, Single Use Soft Contact Lens With A Sensor And Antenna Embedded In It, Allowing For Continuous Wireless Recording Of Changes In Ocular Dimension. An External Adhesive Antenna Worn Around The Eye Is Used To Sen |
| Target Area | Cornea Of The Eye |
| Regulation Description | Diurnal Pattern Recorder System. |
| 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 | 886.1925 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4407 |
| Device | Ocular Pattern Recorder |
| Product Code | PLZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diurnal Pattern Recorder System. |
| CFR Regulation Number | 886.1925 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SENSIMED AG | ||
GRANTED | 1 | |