# K233295: LFR-260

- Pathway: 510(k) (Traditional)
- Applicant: Evolution Optiks Limited
- Decided: May 31, 2024 after 245 days
- Product code: SBI (Manual Refractor, 3d Display)
- Device class: 1
- Regulation: 21 CFR 886.1770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K936205 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936205: Comprehensive Phoropter, MDR-680, Canon USA, Inc. (1994) Summary page 5.

## Indications for use
The LFR-260 is a portable manual refractor providing capabilities to the eyecare provider to perform distance vision testing and subjectively measure sphere, cylinder and axis refractive errors in patients aged from 12-65 years old with healthy visual systems. The device measures spherical error in the range of -10 to +15D and measures cylinder error within +/- 2.5D.

Source page: https://510kreport.com/device/K233295
Methodology: https://510kreport.com/methodology