← FDA Medical Device Classifications
Strabismus Detection Device
PMW · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1342
Classification
- FDA Product Code
PMW- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 886.1342
- Review panel
- OP
- Medical specialty
- Ophthalmic
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For the automated detection of misalignment of the visual axes for prescription use only.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown