| Device Type ID | 4147 |
| Device Name | Loupe, Binocular, Low Power |
| Regulation Description | Low-power Binocular Loupe. |
| 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) Exempt |
| CFR Regulation Number | 886.5120 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HJH |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4147 |
| Device | Loupe, Binocular, Low Power |
| Product Code | HJH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Low-power Binocular Loupe. |
| CFR Regulation Number | 886.5120 [🔎] |
| Device Problems | |
|---|---|
Temperature Problem | 1 |
| Total Device Problems | 1 |