Home / 510(k) Clearances / K191144

510(k) K191144

Cellvizio 100 Series System with Confocal Miniprobes by Mauna Kea Technologies — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2020
Date Received
April 30, 2019
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 Mauna Kea Technologies

  • K220477 — Cellvizio 100 series system with confocal Miniprobes (April 11, 2022)
  • K212322 — Cellvizio I.V.E. system with Confocal Miniprobes (August 18, 2021)
  • K193416 — Cellvizio I.V.E. with Confocal Miniprobes (February 28, 2020)
  • K183640 — Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobe (February 22, 2019)
  • K180270 — Cellvizio 100 Series Systems with Confocal Miniprobes (May 22, 2018)
  • K172844 — Cellvizio 100 Series System with Confocal Miniprobes (December 15, 2017)
  • K171345 — Cellvizio 100 Series Systems with Confocal Miniprobes (August 4, 2017)
  • K160416 — CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal M (May 20, 2016)
  • K150831 — Cellvizio 100 Series System with Confocal Miniprobes (December 22, 2015)
  • K151593 — Cellvizio 100 Series System with Confocal Miniprobes (October 23, 2015)

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)
  • K260108 — L12 LED Light Source with AIM (February 12, 2026)
  • K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040) (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)