Data / Medical devices / France / Mauna Kea Technologies
Mauna Kea Technologies: FDA-registered device maker in PARIS Ile-de-France, France, 16 510(k) clearances
Mauna Kea Technologies is registered with the FDA (registration 3004542960) in PARIS Ile-de-France, France. It lists 3 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004542960
- Address
- 9, Rue D Enghien, PARIS Ile-de-France, France, F-75010
- Owner or operator
- Mauna Kea Technologies (9074201)
- Roles
- Manufacturer
- First device listed
- August 19, 2011
- Registered through
- 2026
- Brand names listed
- AQ-Flex 19 -C, AlveoFlex M Confocal Miniprobe, CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM), CYSTOFLEX F, CelioFlex UHD Confocal Miniprobes to be used with Cellvizio 100 Series Systems, CelioFlex UHD 5, CelioFlexUHD 5-C, Cellvizio 100 Series and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Confocal Optical Imaging | OWN | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope, Neurological | GWG | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 11, 2022 | K220477 | Cellvizio 100 series system with confocal Miniprobes | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| February 28, 2020 | K193416 | Cellvizio I.V.E. with Confocal Miniprobes | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| February 22, 2019 | K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| May 22, 2018 | K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | GWG | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| December 15, 2017 | K172844 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| August 4, 2017 | K171345 | Cellvizio 100 Series Systems with Confocal Miniprobes | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| May 20, 2016 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| December 22, 2015 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| October 23, 2015 | K151593 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| September 25, 2014 | K141358 | CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| July 25, 2014 | K133466 | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM) | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| February 25, 2014 | K132389 | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED | OWN | Substantially Equivalent | Daniel & Daniel Consulting | accessdata.fda.gov |
| April 18, 2013 | K123676 | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| September 4, 2012 | K122042 | CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| April 20, 2012 | K120208 | CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES | OWN | Substantially Equivalent | Mauna Kea Technologies | accessdata.fda.gov |
| August 8, 2011 | K111047 | CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES | OWN | Substantially Equivalent | Mauna Kea Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscope, Neurological
- All makers of Confocal Optical Imaging
- All makers of Laparoscope, General & Plastic Surgery
Updated April 11, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.