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510(k) K254242

KARL STORZ ICG Imaging System with RUBINA® Lens by Karl Storz SE & CO. KG — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2026
Date Received
December 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

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