| Device Type ID | 4172 |
| Device Name | Refractor, Manual, Non-powered, Including Phoropter |
| Regulation Description | Manual Refractor. |
| 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 | 886.1770 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HKN |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4172 |
| Device | Refractor, Manual, Non-powered, Including Phoropter |
| Product Code | HKN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Refractor. |
| CFR Regulation Number | 886.1770 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 32 |
Hinge | 29 |
Holder | 25 |
Heart Valve Sewing Ring | 7 |
Device Component Or Accessory | 3 |
Device Handling Problem | 2 |
Insufficient Information | 1 |
| Total Device Problems | 99 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nidek Inc | II | Mar-24-2016 |
| 2 | Nidek Inc | II | Jun-23-2014 |
| 3 | Nidek Inc. | III | Dec-21-2018 |
| 4 | Reliance Medical Products Inc | II | Apr-09-2018 |