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 Samantree Medical SA.
FDA 510(k) Cleared Confocal Optical Imaging Devices (Product Code OWN)
About Product Code OWN - Regulatory Context
510(k) Submission Activity
61 total 510(k) submissions under product code OWN since 2011, with 61 receiving FDA clearance (average review time: 131 days).
Submission volume has remained relatively stable over the observed period, with 9 submissions in the last 24 months.
FDA Review Time
Recent submissions under OWN have taken an average of 184 days to reach a decision - up from 122 days historically. Manufacturers should account for longer review timelines in current project planning.
OWN devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →