PMW

Strabismus Detection Device

Product code

PMW

Device name

Strabismus Detection Device

Device class

Class 2

21 CFR

21 CFR 886.1342

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

For the automated detection of misalignment of the visual axes for prescription use only.

Definition text from the FDA device classification database (U.S. federal government work, public domain).