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510(k) K193416

Cellvizio I.V.E. with Confocal Miniprobes by Mauna Kea Technologies — Product Code OWN

K193416 is an FDA 510(k) premarket notification submitted by Mauna Kea Technologies for the device "Cellvizio I.V.E. with Confocal Miniprobes". The FDA issued a decision of Substantially Equivalent on February 28, 2020. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Mauna Kea Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2020
Date Received
December 9, 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)
  • K191144 — Cellvizio 100 Series System with Confocal Miniprobes (January 24, 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

  • K254180 — PerfusiX-Imaging (July 24, 2026)
  • K242163 — SmartSurgN Visualization System (April 20, 2026)
  • 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)

FDA data resources