Pure Global AI
FDA product code PMW

Strabismus Detection Device

OphthalmicClass 221 CFR 886.1342
Verified
US regulatory classifications
US Product Code (FDA)
PMW
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 886.1342
View 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.

Search keywords

Click to search for similar devices in our global database

01Strabismus detector02Eye alignment03Vision screening04Ophthalmology device05Eye test06Amblyopia detector07Squint test08Pediatric ophthalmology09Eye disorder10Ocular alignment
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.