# K153606: LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew
- Decided: Jun 2, 2016 after 168 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: 6 generations back to K833587 (1983). 35 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101734: Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes, Visionscope Technologies, LLC (2010) Summary page 4.
- K070266: 560 High Definition Camera System, Smith & Nephew, Inc. (2007) Summary page 4.

## Most influential descendants
- K190367: Smith & Nephew Tablet Application (2019), 3 descendants of its own
- K192876: INTELLIO Tablet Application (2020), 2 descendants of its own
- K203566: Tablet Application (2021), 1 descendant of its own
- K191177: LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head (2019), 1 descendant of its own
- K221740: Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4K Camera Control Unit, Non-Network Enabled (72205448) (2022), 0 descendants of its own

## Indications for use
The Lens Integrated system and LENS Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs and canals. Additionally, the LENS Integrated System and Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope. The LENS Application, when used in conjunction with the LENS Integrated System WiFi version, is indicated for capture of still and motion pictures, patient file management and limited redundant control of the LENS camera control unit within articular cavities, body cavities, hollow organs, canals and the thoracic cavity.

Source page: https://510kreport.com/device/K153606
Methodology: https://510kreport.com/methodology