# K173332: OMNI Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Sight Sciences, Inc.
- Decided: Dec 21, 2017 after 59 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: 7 generations back to K902835 (1990). 17 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080067: Iscience Interventional Ophthalmic Microcatheter, Iscience Interventional (2008) Summary page 4.
- K171905: VISCO 360 Viscosurgical System, Sight Sciences, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K243503: VIA360™ Surgical System (2025), 0 descendants of its own
- K211680: Streamline Surgical System (2021), 0 descendants of its own

## Indications for use
The OMNI™ Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or Healon GV® from Abbott Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

Source page: https://510kreport.com/device/K173332
Methodology: https://510kreport.com/methodology