# K042740: Isc-1000 Pentax Confocal Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: Oct 19, 2004 after 15 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: 1 generation back to K912581 (1991). 1 ancestor in all.
16 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912581: Zeiss Confocal Laser Scanning Ophthalmoscope (Clso), Carl Zeiss, Inc. (1991) Summary page 1.

## Most influential descendants
- K061666: Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex (2006), 13 descendants of its own
- K051585: F-400 System (2005), 13 descendants of its own
- K111047: Cellvizio 100 Series System with Confocal Miniprobes (2011), 12 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own

## Indications for use
The Pentax confocal laser system is a required accessory for legally marketed video endoscopes equipped with a confocal laser imaging module. The system is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by the endoscope. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Source page: https://510kreport.com/device/K042740
Methodology: https://510kreport.com/methodology