510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183640Substantially Equivalent

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes

Mauna Kea Technologies, Paris, FR / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183640 is the FDA 510(k) clearance record for Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes, a class II device, cleared for Mauna Kea Technologies on under FDA product code OWN (Confocal Optical Imaging). FDA's definition for product code OWN reads: "Collection of light signals for visualization of cellular microstructures". FDA records list 19 510(k) clearances for Mauna Kea Technologies, from to . As of , FDA records show no recalls naming K183640.

Clearance record

Decision date
Received
(58 days to decision)
Product code
OWN Confocal Optical Imaging
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mauna Kea Technologies 9 Rue D'Enghien, Paris, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWN

Trailing 12 months
8 clearances under product code OWN in the twelve months to October 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWN, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20264
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260