| Device Type ID | 4293 |
| Device Name | Lens, Contact (other Material) - Daily |
| Regulation Description | Rigid Gas Permeable 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) Contact Lenses And Retinal Devices Branch (CLRD) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.5916 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HQD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4293 |
| Device | Lens, Contact (other Material) - Daily |
| Product Code | HQD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rigid Gas Permeable Contact Lens. |
| CFR Regulation Number | 886.5916 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED VISION TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON FOUNDATION FOR SIGHT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONTAMAC LTD. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
COOPERVISION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARAGON VISION SCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNERGEYES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 19 |
Appropriate Term/Code Not Available | 12 |
Insufficient Information | 3 |
Use Of Device Problem | 1 |
Difficult To Remove | 1 |
| Total Device Problems | 36 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alden Optical | III | Sep-06-2018 |