PIC — Oral Electronic Vision Aid Class II
FDA product code PIC covers "Oral Electronic Vision Aid", a Class II medical device regulated under 21 CFR 886.5905. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PIC
- Device Class
- Class II
- Regulation Number
- 886.5905
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)