510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K233295Substantially Equivalent

Lfr-260

Evolution Optiks Limited, Christ Church, BB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233295 is the FDA 510(k) clearance record for LFR-260, a class I device, cleared for Evolution Optiks Limited on under FDA product code SBI (Manual Refractor, 3d Display). FDA's definition for product code SBI reads: "A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye". FDA records list one 510(k) clearance for Evolution Optiks Limited. As of , FDA records show no recalls naming K233295.

Clearance record

Decision date
Received
(245 days to decision)
Product code
SBI Manual Refractor, 3d Display
Regulation
21 CFR 886.1770
Device class
Class I
Review panel
Ophthalmic
Applicant
Evolution Optiks Limited Pasea Financial Centre, Christ Church, BB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SBI

Trailing 12 months

FDA records hold no clearances under product code SBI in the trailing twelve months.

FDA records show no clearances under product code SBI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SBI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260