# K143205: Viscoelastic Injector

- Pathway: 510(k) (Special)
- Applicant: Sight Sciences, Inc.
- Decided: Dec 5, 2014 after 28 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: 5 generations back to K902835 (1990). 9 ancestors in all.
9 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)
- K132494: Viscoelastic Injector, Sight Sciences, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K232214: OMNI Surgical System (2023), 1 descendant of its own
- K253760: OMNI Ultra Surgical System (1-110) (2026), 0 descendants of its own

## Indications for use
The Sight Sciences Viscoelastic Injector is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon™ or HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISC™ from Alcon, during ophthalmic surgery.

Source page: https://510kreport.com/device/K143205
Methodology: https://510kreport.com/methodology