# K231106: Accuject Refra Injector AR2900

- Pathway: 510(k) (Traditional)
- Applicant: Medicel AG
- Decided: Sep 19, 2023 after 153 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930320 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101134: Visian Nanopoint 2.0 Injector Model LP604430, Medicel AG (2010) Summary page 4.

## Indications for use
The ACCUJECT™ REFRA Injector is a device intended to fold and insert STAAR Surgical Collamer Phakic One Piece Intraocular Lenses, Model EVO/EVO+ VISIAN® Implantable Collamer® Lens, for surgical placement in the human eye.

Source page: https://510kreport.com/device/K231106
Methodology: https://510kreport.com/methodology