SBI — Manual Refractor, 3d Display Class I

FDA Device Classification

Classification Details

Product Code
SBI
Device Class
Class I
Regulation Number
886.1770
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233295evolution optiks limitedLFR-260May 31, 2024