OWN — Confocal Optical Imaging Class II
FDA product code OWN covers "Confocal Optical Imaging", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K242163 | smartsurgn | SmartSurgN Visualization System | April 20, 2026 |
| 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 |