Device Type ID | 4178 |
Device Name | Prism, Fresnel, Ophthalmic |
Regulation Description | Ophthalmic Fresnel Prism. |
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 | 886.1655 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HKT |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4178 |
Device | Prism, Fresnel, Ophthalmic |
Product Code | HKT |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Ophthalmic Fresnel Prism. |
CFR Regulation Number | 886.1655 [🔎] |