# K201953: OMNI PLUS Surgical System

- Pathway: 510(k) (Special)
- Applicant: Sight Sciences, Inc.
- Decided: Aug 11, 2020 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: 8 generations back to K902835 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173332: OMNI Surgical System, Sight Sciences, Inc. (2017) Summary page 4.

## Indications for use
The OMNI® PLUS Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® PRO or Healon GV® PRO from Johnson & Johnson Vision, 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/K201953
Methodology: https://510kreport.com/methodology