OWN — Confocal Optical Imaging Class II
Classification Details
- Product Code
- OWN
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Collection of light signals for visualization of cellular microstructures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254242 | karl storz se and co. kg | KARL STORZ ICG Imaging System with RUBINA® Lens | February 26, 2026 |
| K251852 | vpix medical | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | February 13, 2026 |
| K260108 | stryker endoscopy | L12 LED Light Source with AIM | February 12, 2026 |
| K253972 | karl storz se and co. kg | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | February 12, 2026 |
| K251336 | olympus medical systems | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE I | November 12, 2025 |
| K243711 | wuxi hisky medical technologies co | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging Sys | July 24, 2025 |
| K243591 | optosurgical | OPTOVISION Endoscopic Light Source Unit | February 19, 2025 |
| K241275 | samantree medical | Histolog® Scanner (Hardware 2.4, Software 3.3) | August 19, 2024 |
| K233333 | karl storz se and co. kg | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | November 21, 2023 |
| K232857 | karl storz se and co. kg | KARL STORZ ICG Imaging System | November 6, 2023 |
| K231854 | stryker | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with | September 20, 2023 |
| K231344 | activ surgical | ActivSight Intraoperative Imaging System | August 2, 2023 |
| K230407 | guangdong optomedic technologies | FloNavi Open Field Fluorescence Imaging System | July 17, 2023 |
| K230754 | stryker | L12 LED Light Source with AIM | April 11, 2023 |
| K213943 | smartsurgn incorporated | SmartSurgN Visualization System | November 29, 2022 |
| K223020 | visionsense | VS3-Iridium System (VS3-IR) | October 28, 2022 |
| K221611 | stryker | 780 nm L11 LED Light Source with AIM | June 29, 2022 |
| K220477 | mauna kea technologies | Cellvizio 100 series system with confocal Miniprobes | April 11, 2022 |
| K210265 | visionsense | VS3 Iridium Sytem | November 22, 2021 |
| K212695 | karl storz endoscopy america | KARL STORZ ICG Imaging System | November 15, 2021 |