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510(k) K233295

LFR-260 by Evolution Optiks Limited — Product Code SBI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 31, 2024
Date Received: September 29, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Manual Refractor, 3d Display
Device Class: Class I
Regulation Number: 886.1770
Review Panel: OP
Submission Type

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