# K243711: Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Hisky Medical Technologies Co., Ltd.
- Decided: Jul 24, 2025 after 234 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: 13 generations back to K935844 (1995). 83 ancestors in all.
No later device cites it as a predicate yet.
1 of 84 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191144: Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies (2020) Summary page 5.

## Indications for use
The Confocal Microprobe Imaging System can enter the human body cavity or surgical channel through an endoscope, allowing confocal laser imaging of the microstructure of tissues, including but not limited to the identification of cells, vessels and their organization or architecture.

Source page: https://510kreport.com/device/K243711
Methodology: https://510kreport.com/methodology