# K141091: Raysert Plus Injector

- Pathway: 510(k) (Special)
- Applicant: Rayner Intraocular Lenses, Ltd.
- Decided: May 28, 2014 after 30 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914311 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132002: Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small Incision Disposable Injector, Rayner Intraocular Lenses, Ltd. (2014) Summary page 1.

## Recalls of this device
- Mar 17, 2020 · Class II · Z-1753-2020: RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray 

## Indications for use
The RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10) is intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling.

Source page: https://510kreport.com/device/K141091
Methodology: https://510kreport.com/methodology