← FDA Medical Device Classifications
Oral Electronic Vision Aid
PIC · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5905
Classification
- FDA Product Code
PIC- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 886.5905
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown