Cellvizio 100 Series System with Confocal Miniprobes
FDA 510(k) K191144 · Mauna Kea Technologies
510(k) numberK191144
Submission
- Device name
- Cellvizio 100 Series System with Confocal Miniprobes
- Applicant
- Mauna Kea Technologies
Paris, FR - Received
- April 30, 2019
- Decision date
- January 24, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
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| K242163 | SmartSurgN Visualization SystemOWN · Traditional | SmartsurgN, Inc. | 04/20/2026SE |
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| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)OWN · Traditional | VPIX Medical, Inc. | 02/13/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | Stryker Endoscopy | 02/12/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | Karl Storz SE & CO. KG | 02/12/2026SE |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…OWN · Traditional | Olympus Medical Systems Corp. | 11/12/2025SE |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…OWN · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 07/24/2025SE |
| K243591 | OPTOVISION Endoscopic Light Source UnitOWN · Traditional | Optosurgical, LLC | 02/19/2025SE |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3)OWN · Traditional | Samantree Medical SA | 08/19/2024SE |
More from Samantree Medical SA
| 510(k) | Device | Decision |
|---|---|---|
| K220477 | Cellvizio 100 series system with confocal MiniprobesOWN · Traditional | 04/11/2022SE |
| K212322 | Cellvizio I.V.E. system with Confocal MiniprobesOWN · Special | 08/18/2021SE |
| K193416 | Cellvizio I.V.E. with Confocal MiniprobesOWN · Traditional | 02/28/2020SE |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesOWN · Special | 02/22/2019SE |
| K180270 | Cellvizio 100 Series Systems with Confocal MiniprobesGWG · Traditional | 05/22/2018SE |
| K172844 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 12/15/2017SE |
| K171345 | Cellvizio 100 Series Systems with Confocal MiniprobesOWN · Traditional | 08/04/2017SE |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesOWN · Special | 05/20/2016SE |
| K150831 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 12/22/2015SE |
| K151593 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 10/23/2015SE |
Questions and answers
When was Cellvizio 100 Series System with Confocal Miniprobes cleared by the FDA?
Cellvizio 100 Series System with Confocal Miniprobes (K191144) received a 510(k) decision of Substantially Equivalent on January 24, 2020, 269 days after the submission was received.
What is the product code of K191144?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.