FDA Product Code OWN: Confocal Optical Imaging
Under FDA product code OWN, confocal optical imaging systems are cleared for real-time in vivo visualization of cellular and tissue microstructure during endoscopic procedures.
These devices use focused laser illumination and pinhole optics to generate high-resolution optical cross-sections of tissue at the cellular level without biopsy. They enable "optical biopsy" of gastrointestinal mucosa, guiding targeted tissue sampling and real-time assessment of lesion histology.
OWN devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Karl Storz SE & CO. KG, Stryker and Olympus Medical Systems Corp..
List of Confocal Optical Imaging devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Confocal Optical Imaging devices (product code OWN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →