# K050716: Iscience Surgical Viscoinjector

- Pathway: 510(k) (Traditional)
- Applicant: Iscience Surgical Corporation
- Decided: Apr 21, 2005 after 31 days
- Product code: MRH (Pump, Infusion, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K902835 (1990). 7 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993039: Viscous Fluid Injector System Module (CX5700), Bausch & Lomb, Inc. (2000) Summary page 2.
- K890783: Grieshaber Viscoelastic Injection System, Grieshaber & Co. (1989) Summary page 2.
- K954842: D.O.R.C. Vfi/Vfe System, Dutch Ophthalmic USA, Inc. (1996) Summary page 2.
- K963434: Viscous Fluid System, Escalon Trek Medical (1996) Summary page 2.

## Most influential descendants
- K132494: Viscoelastic Injector (2013), 10 descendants of its own
- K143205: Viscoelastic Injector (2014), 9 descendants of its own
- K171905: VISCO 360 Viscosurgical System (2017), 8 descendants of its own
- K173332: OMNI Surgical System (2017), 6 descendants of its own
- K202678: OMNI Surgical System (2021), 2 descendants of its own

## Indications for use
The iScience Surgical Ophthalmic Viscolnjector is a manually operated device for precision delivery of small amounts of viscous fluid such as a sterile viscoelastic solution pre-packaged in a cartridge, for example Healon, HealonGV and Healon5 manufactured by Advanced Medical Optics Inc., and Ocucoat manufactured by Bausch and Lomb.

Source page: https://510kreport.com/device/K050716
Methodology: https://510kreport.com/methodology