DeviceClearance

Product code SBI— Ophthalmic

LFR-260

Classification name
Manual Refractor, 3d Display
Device class
Class 1
Regulation
21 CFR 886.1770
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.”

— U.S. Food and Drug Administration, device classification record for product code SBI under 21 CFR 886.1770, via openFDA

Market context for product code SBI

FDA has cleared 1 device under product code SBI, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code SBI

Recent clearances under product code SBI

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