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510(k) K202678

OMNI Surgical System by Sight Sciences, Inc. — Product Code MRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2021
Date Received
September 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Ophthalmic
Device Class
Class II
Regulation Number
880.5725
Review Panel
OP
Submission Type

Other clearances by Sight Sciences, Inc.

  • K242786 — TearCare MGX System (April 15, 2025)
  • K231084 — TearCare MGX System (December 27, 2023)
  • K232214 — OMNI Surgical System (August 25, 2023)
  • K213045 — TearCare System (December 21, 2021)
  • K201953 — OMNI PLUS Surgical System (August 11, 2020)
  • K173332 — OMNI Surgical System (December 21, 2017)
  • K171905 — VISCO 360 Viscosurgical System (July 27, 2017)
  • K143205 — Viscoelastic Injector (December 5, 2014)
  • K132494 — VISCOELASTIC INJECTOR (October 22, 2013)

Other clearances for product code MRH

  • K243503 — VIA360™ Surgical System (February 14, 2025)
  • K232214 — OMNI Surgical System (August 25, 2023)
  • K213173 — TrabEx Pro (June 8, 2022)
  • K212797 — iPrime Viscodelivery System (January 6, 2022)
  • K211680 — Streamline Surgical System (October 8, 2021)
  • K201953 — OMNI PLUS Surgical System (August 11, 2020)
  • K173332 — OMNI Surgical System (December 21, 2017)
  • K171905 — VISCO 360 Viscosurgical System (July 27, 2017)
  • K143205 — Viscoelastic Injector (December 5, 2014)
  • K132494 — VISCOELASTIC INJECTOR (October 22, 2013)