# K193026: Visera Elite II Video System Center, Visera Elite II Endoeye 3D

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Apr 3, 2020 after 156 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 10 generations back to K931154 (1993). 40 ancestors in all.
5 later devices descend from it; 1 cites it directly.
3 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190, Olympus Medical Systems Corp. (2012) Summary page 6.
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190, Olympus Medical Systems Corp. (2013) Summary page 6.
- K190744: Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A), Olympus Winter & Ibe GmbH (2019) Summary page 6.
- K111788: Endoeye HD II, Olympus America, Inc. (2012) Summary page 6.

## Most influential descendants
- K201200: Visera Elite II Video System Center (2020), 4 descendants of its own
- K242067: Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source Olympus CLL-S700; 4K Camera Head Olympus CH-S700-XZ-EA (2025), 2 descendants of its own
- K262079: 4K Camera Head OLYMPUS CH-S700-08-LB (2026), 0 descendants of its own
- K251336: VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (2025), 0 descendants of its own
- K202646: Visera Elite II Video System Center (2020), 0 descendants of its own

## Indications for use
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. This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs. The device is also indicated for visualization during transanal and transvaginal natural orifice surgery.

Source page: https://510kreport.com/device/K193026
Methodology: https://510kreport.com/methodology