Definition: For The Automated Detection Of Misalignment Of The Visual Axes For Prescription Use Only.
| Device Type ID | 4408 |
| Device Name | Strabismus Detection Device |
| Physical State | Hardware Components Are Integrated In A Housing (e.g., Plastic Enclosure), Which Includes The Image Acquisition Optics, The System Computer And Visual Display. User Input Is Limited To Only Basic Device Function, Such As: “Background” Button For Back |
| Technical Method | Includes A Laser Diode (Scanning Laser) That Emits A Beam Of Polarized Laser Light Onto The Retina Based On The Principle Of Retinal Birefringence Scanning (birefringent Nerve Fibers That Surround The Fovea Change The Polarization State Of Reflected |
| Target Area | The Target Area Is The Eye. |
| Regulation Description | Strabismus Detection Device. |
| 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 | 886.1342 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PMW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4408 |
| Device | Strabismus Detection Device |
| Product Code | PMW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Strabismus Detection Device. |
| CFR Regulation Number | 886.1342 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
REBISCAN, INC. | ||
GRANTED | 1 | |