# K093624: Optiscan Model Optiscan Ceis

- Pathway: 510(k) (Traditional)
- Applicant: Optiscan Pty., Ltd.
- Decided: Mar 5, 2010 after 102 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: 2 generations back to K912581 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042740: Isc-1000 Pentax Confocal Laser System, Pentax Medical Company (2004) Summary page 1.

## Indications for use
The Confocal Endoscopic Imaging System (GElS) is intended to allow confocal laser imaging of the internal rnicrostrUcture of tissues in the anatomical track accessed by legally marketed video endoscopes (equipped with a confocal laser imaging module), during endoscopic medical examination procedures. 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/K093624
Methodology: https://510kreport.com/methodology