Device Type ID | 4373 |
Device Name | Lens, Contact, For Color Vision Deficiency |
Regulation Description | Soft (hydrophilic) 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 | 886.5925 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NCZ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4373 |
Device | Lens, Contact, For Color Vision Deficiency |
Product Code | NCZ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Soft (hydrophilic) Contact Lens. |
CFR Regulation Number | 886.5925 [🔎] |