# K200542: Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jul 17, 2020 after 136 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K930667 (1994). 106 ancestors in all.
No later device cites it as a predicate yet.
3 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152583: KARL STORZ Endoscopic ICG Imaging System, KARL STORZ Endoscopy-America, Inc. (2016) Summary page 8.
- K150633: ULTRA Telescopes, Olympus Winter & Ibe GmbH (2015) Summary page 8.
- K190449: Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head, Olympus Medical Systems Corp. (2019) Summary page 9.

## Indications for use
The VISERA ELITE II Infrared Imaging System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. The VISERA ELITE II Infrared Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the VISERA ELITE II Infrared Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. The light source has been designed to be used with Olympus endoscopes, video system centers, light guide cables, and other ancillary equipment for endoscopic observation through visible and near-infrared fluorescence imaging with fluorescence agent. The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal natural orifice surgery. In combination with a compatible infrared imaging system, the telescope allows for fluorescence imaging.

Source page: https://510kreport.com/device/K200542
Methodology: https://510kreport.com/methodology