# K132002: Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small Incision Disposable Injector

- Pathway: 510(k) (Traditional)
- Applicant: Rayner Intraocular Lenses, Ltd.
- Decided: Mar 27, 2014 after 269 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: 5 generations back to K914311 (1992). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091507: Rayner Small Incision Single Use Soft Tipped Injector, Model R-Inj-04/18, Rayner Intraocular Lenses, Ltd. (2009) Summary page 1.

## Most influential descendants
- K143307: RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector (2014), 0 descendants of its own
- K141091: Raysert Plus Injector (2014), 0 descendants of its own

## Indications for use
The single use disposable Injectors (Model R-INJ-04 and Model R-INJ-04/18) are 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 labelling.

Source page: https://510kreport.com/device/K132002
Methodology: https://510kreport.com/methodology