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U.S. Department of Health and Human Services

Product Classification

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Device confocal optical imaging
Regulation Description Endoscope and accessories.
Definition Collection of light signals for visualization of cellular microstructures.
Physical State Usually include optical fibers, light collection cameras and computer-based central processing unit
Technical Method Collects reflected and scattered light signals from the areas of interest for image reconstruction
Target Area soft tissue, blood vessel and other vessels in the body
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General & Plastic Surgery
Product CodeOWN
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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