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510(k) K223020

VS3-Iridium System (VS3-IR) by Visionsense, Ltd. — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2022
Date Received
September 29, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

Other clearances by Visionsense, Ltd.

  • K210265 — VS3 Iridium Sytem (November 22, 2021)
  • K171208 — Trans-anal Introducer (February 5, 2018)
  • K153548 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (February 22, 2016)
  • K152204 — VS3-IR system (October 28, 2015)
  • K150018 — VS3-IR-MMS System (June 17, 2015)
  • K141002 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (June 26, 2014)
  • K131434 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (July 16, 2013)
  • K123467 — VS3 (April 17, 2013)
  • K082355 — VISIONSENSE STEREOSCOPIC VISION SYSTEM (December 15, 2008)
  • K082667 — VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) (October 30, 2008)

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