Cleared Traditional

K233295 - LFR-260 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K233295 · Evolution Optiks Limited · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
245d
Days
Class 1
Risk

K233295 is an FDA 510(k) clearance for the LFR-260. Classified as Manual Refractor, 3d Display (product code SBI), Class I - General Controls.

Submitted by Evolution Optiks Limited (Christ Church, BB). The FDA issued a Cleared decision on May 31, 2024 after a review of 245 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1770 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Evolution Optiks Limited devices

Submission Details

510(k) Number K233295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date May 31, 2024
Days to Decision 245 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 110d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SBI Manual Refractor, 3d Display
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1770
Definition A 3d Display Manual Refractor Is An Optical Device Intended To Measure The Refractive Error Of The Eye.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.