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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 the device name listed in this FDA 510(k) record. The listed applicant is Sight Sciences, Inc.. It received FDA 510(k) clearance on 2020-08-11 under 510(k) 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. The listed applicant is Sight Sciences, Inc.. The 510(k) number is K201953.

When did OMNI PLUS Surgical System receive FDA 510(k) clearance?

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

Who is the listed applicant for OMNI PLUS Surgical System?

The FDA 510(k) record lists Sight Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06948773A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)ACTIVE_NOT_RECRUITINGNCT07365735TearCare MGX™ System With and Without Warming HoldCOMPLETED

Other records listing Sight Sciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253760OMNI Ultra Surgical System (1-110)K252409TearCare MGX SystemK242786TearCare MGX SystemK231084TearCare MGX SystemK232214OMNI Surgical SystemK213045TearCare System

View all 10 devices →

Related Devices (Code: MRH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc.K243503VIA360™ Surgical SystemNew World Medical, Inc.K232214OMNI Surgical SystemSight Sciences, Inc.K213173TrabEx ProMicrosurgical Technologies, Inc.K212797iPrime Viscodelivery SystemGlaukosK211680Streamline Surgical SystemNew World Medical, Inc.

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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