# K152357: MicroSTAAR Injector System Cartridges

- Pathway: 510(k) (Special)
- Applicant: STAAR Surgical Company
- Decided: Oct 30, 2015 after 71 days
- Product code: KYB (Lens, Guide, Intraocular)
- 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101782: Microstaar Msi Injector System Cartridge, Staar Japan (2010) Summary page 4.

## Indications for use
The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.

Source page: https://510kreport.com/device/K152357
Methodology: https://510kreport.com/methodology