L12 LED Light Source with AIM
FDA 510(k) K260108 · Stryker Endoscopy
510(k) numberK260108
Submission
- Device name
- L12 LED Light Source with AIM
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- January 14, 2026
- Decision date
- February 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| 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 L12 LED Light Source with AIM cleared by the FDA?
L12 LED Light Source with AIM (K260108) received a 510(k) decision of Substantially Equivalent on February 12, 2026, 29 days after the submission was received.
What is the product code of K260108?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.