DeviceClearance

Product code PMW— Ophthalmic

PEDIATRIC VISION SCANNER

Classification name
Strabismus Detection Device
Device class
Class 2
Regulation
21 CFR 886.1342
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PMW under 21 CFR 886.1342, via openFDA

Market context for product code PMW

FDA has cleared 1 device under product code PMW, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PMW

Recent clearances under product code PMW

Data sourced from openFDA. This site is unofficial and independent of the FDA.