FDA.reportPublic FDA data

510(k) K232214

Device
OMNI Surgical System
Applicant
Sight Sciences, Inc.
510(k) number
K232214
Product code
MRH
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-25
Date received
2023-07-26
Regulation
880.5725
Classification name
Pump, Infusion, Ophthalmic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ranjani Madhavan
Address
4040 Campbell Ave. Suite 100 Menlo Park CA US 94025 94025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243503VIA360™ Surgical SystemNew World Medical, Inc.2025-02-14
K213173TrabEx ProMicrosurgical Technologies, Inc.2022-06-08
K212797iPrime Viscodelivery SystemGlaukos2022-01-06
K211680Streamline Surgical SystemNew World Medical, Inc.2021-10-08
K202678OMNI Surgical SystemSight Sciences, Inc.2021-03-01
K201953OMNI PLUS Surgical SystemSight Sciences, Inc.2020-08-11
K173332OMNI Surgical SystemSight Sciences, Inc.2017-12-21
K171905VISCO 360 Viscosurgical SystemSight Sciences, Inc.2017-07-27
K143205Viscoelastic InjectorSight Sciences, Inc.2014-12-05
K132494VISCOELASTIC INJECTORSight Sciences, Inc.2013-10-22
K050716ISCIENCE SURGICAL VISCOINJECTORIscience Surgical Corporation2005-04-21
K000420SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003Retinalabs.Com2000-05-08
K993039VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)Bausch & Lomb, Inc.2000-01-07
K981907V.F.I.-VISCOUS FLUID INFUSION TUBING SETPeregrine Surgical , Ltd.1998-08-04
K974253CPD COMMANDERScieran Technologies, Inc.1998-02-25