Home / 510(k) Clearances / K210265

510(k) K210265

VS3 Iridium Sytem by Visionsense, Ltd. — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2021
Date Received
February 1, 2021
Clearance Type
Traditional
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.

  • K223020 — VS3-Iridium System (VS3-IR) (October 28, 2022)
  • 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)

Other clearances for product code OWN

  • K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens (February 26, 2026)
  • K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (February 13, 2026)
  • K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040) (February 12, 2026)
  • K260108 — L12 LED Light Source with AIM (February 12, 2026)
  • K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE I (November 12, 2025)
  • K243711 — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging Sys (July 24, 2025)
  • K243591 — OPTOVISION Endoscopic Light Source Unit (February 19, 2025)
  • K241275 — Histolog® Scanner (Hardware 2.4, Software 3.3) (August 19, 2024)
  • K233333 — KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (November 21, 2023)
  • K232857 — KARL STORZ ICG Imaging System (November 6, 2023)