| Device Type ID | 4173 |
| Device Name | Refractometer, Ophthalmic |
| Regulation Description | Ophthalmic Refractometer. |
| 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 | 886.1760 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HKO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4173 |
| Device | Refractometer, Ophthalmic |
| Product Code | HKO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ophthalmic Refractometer. |
| CFR Regulation Number | 886.1760 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 24 |
Device Operates Differently Than Expected | 2 |
Human-Device Interface Problem | 1 |
Smoking | 1 |
| Total Device Problems | 28 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nidek Inc | II | Aug-27-2015 |
| 2 | Nidek Inc. | II | Apr-10-2018 |