FDA product code PMW
Strabismus Detection Device
Ophthalmic·Class 2·21 CFR 886.1342
US regulatory classifications
- US Product Code (FDA)
- PMWView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 886.1342View CFR Regulation →
- Medical specialty
- Ophthalmic
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
For the automated detection of misalignment of the visual axes for prescription use only.
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About this record
Strabismus Detection Device is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.