# K090161: Epiphany Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Staar Surgical Co.
- Decided: Jun 9, 2009 after 138 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: 3 generations back to K914311 (1992). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052651: C-Flex System Single Use Disposable Injector, Model R-Inj-02, Rayner Surgical, Inc. (2006) Summary page 1.
- K970727: Mport Foldable Lens Placement System, Chiron Vision Corp. (1997) Summary page 1.
- K002556: Ceeon Easysert Intraocular Lens Injector, Model Imp-1, Pharmacia & Upjohn Co. (2000) Summary page 1.
- K940593: Disposable Microstaar Injector, Staar Sugical (1994) Summary page 1.
- K954600: Microstaar Injector Models Msi-TD & Msi-PD (Modification), Staar Surgical Co. (1995) Summary page 1.
- K073591: Microstaar Msi Injector Foam Tip System, Staar Surgical Co. (2008) Summary page 1.

## Most influential descendants
- K101782: Microstaar Msi Injector System Cartridge (2010), 2 descendants of its own
- K172375: MicroSTAAR Injector System Cartridges (2017), 0 descendants of its own
- K152357: MicroSTAAR Injector System Cartridges (2015), 0 descendants of its own

## Indications for use
The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Company aspheric three piece Collamer®, Model CQ2015A, and aspheric three piece silicone intraocular lenses, Model AQ2015A, for surgical placement in the human eye.

Source page: https://510kreport.com/device/K090161
Methodology: https://510kreport.com/methodology