| Device Type ID | 4150 |
| Device Name | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Regulation Description | Polymethylmethacrylate (PMMA) Diagnostic Contact Lens. |
| 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 | 886.1385 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HJK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 4150 |
| Device | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Product Code | HJK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polymethylmethacrylate (PMMA) Diagnostic Contact Lens. |
| CFR Regulation Number | 886.1385 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PHAKOS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SENSOR MEDICAL TECHNOLOGY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Volk Optical Inc | III | Mar-15-2016 |
| 2 | Volk Optical Inc | III | May-28-2015 |