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 Stryker, KARL STORZ Endoscopy-America, Inc. and Mauna Kea Technologies.