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FDA 510(k)

OMNI PLUS Surgical System

K-Number: K201953 · 2020-08-11

ApplicantSight Sciences, Inc.
Decision Date2020-08-11
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMNI PLUS Surgical System is a medical device manufactured by Sight Sciences, Inc.. It received FDA 510(k) clearance on 2020-08-11 under approval number K201953. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI PLUS Surgical System?

OMNI PLUS Surgical System is a medical device that received FDA 510(k) clearance on 2020-08-11. It is manufactured by Sight Sciences, Inc.. The 510(k) number is K201953.

When was OMNI PLUS Surgical System approved by the FDA?

OMNI PLUS Surgical System received FDA 510(k) clearance on 2020-08-11, under approval number K201953.

What company makes OMNI PLUS Surgical System?

OMNI PLUS Surgical System is manufactured by Sight Sciences, Inc..

What is the FDA product code for OMNI PLUS Surgical System?

The FDA product code for OMNI PLUS Surgical System is MRH.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Sight Sciences, Inc.

K173332OMNI Surgical System K171905VISCO 360 Viscosurgical System K213045TearCare System K202678OMNI Surgical System K231084TearCare MGX System K232214OMNI Surgical System

View all 9 devices →

Related Devices (Code: MRH)

K173332OMNI Surgical SystemSight Sciences, Inc. K171905VISCO 360 Viscosurgical SystemSight Sciences, Inc. K211680Streamline Surgical SystemNew World Medical, Inc. K202678OMNI Surgical SystemSight Sciences, Inc. K213173TrabEx ProMicrosurgical Technologies, Inc. K212797iPrime Viscodelivery SystemGlaukos

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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