DeviceClearance

Product code QER— Ophthalmic

CLARUS

Classification name
Camera, Ophthalmic, Slit-Scanning
Device class
Class 2
Regulation
21 CFR 886.1120
Advisory panel
Ophthalmic
Total cleared
3
First cleared
Most recent

FDA classification definition

“An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.”

— U.S. Food and Drug Administration, device classification record for product code QER under 21 CFR 886.1120, via openFDA

Market context for product code QER

FDA has cleared 3 devices under product code QER between 2019 and 2025, 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.

Clearances per year

Top applicants under product code QER

Recent clearances under product code QER

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