Cleared Traditional

K233295 - LFR-260

K233295 is an FDA 510(k) clearance for LFR-260, manufactured by Evolution Optiks Limited. The device is a Class 1 Ophthalmic device with product code SBI cleared through the Traditional 510(k) pathway after a 245-day FDA review.

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

FDA 510(k) Submission Details - K233295

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.

SBI Device Classification - Class 1, General Controls

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.