KARL STORZ ICG Imaging System with RUBINA® Lens
FDA 510(k) K254242 · Karl Storz SE & CO. KG
510(k) numberK254242
Submission
- Device name
- KARL STORZ ICG Imaging System with RUBINA® Lens
- Applicant
- Karl Storz SE & CO. KG
Tuttlingen, DE - Received
- December 29, 2025
- Decision date
- February 26, 2026
- 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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| 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 |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitOWN · Traditional | Karl Storz SE & CO. KG | 11/21/2023SE |
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Questions and answers
When was KARL STORZ ICG Imaging System with RUBINA® Lens cleared by the FDA?
KARL STORZ ICG Imaging System with RUBINA® Lens (K254242) received a 510(k) decision of Substantially Equivalent on February 26, 2026, 59 days after the submission was received.
What is the product code of K254242?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.