| Device Type ID | 4336 |
| Device Name | Case, Contact Lens |
| Regulation Description | Soft (hydrophilic) Contact Lens Care Products. |
| 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 | 886.5928 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LRX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 4336 |
| Device | Case, Contact Lens |
| Product Code | LRX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Soft (hydrophilic) Contact Lens Care Products. |
| CFR Regulation Number | 886.5928 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALCON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALCON RESEARCH, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAUSCH & LOMB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DANYANG CHANXIN GLASSES CASES FACTORY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIFTYTWOWAYS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MACA PLASTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NINGBO LISHUNDA ELECTRONICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NINGBO YINZHOU ZONGHAI ARTWARE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVABAY PHARMACEUTICALS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
P L OVERSEAS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VIOPTI LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |