# K233076: Laser Speckle Imaging System (RFLSI CZW)

- Pathway: 510(k) (Traditional)
- Applicant: Rwd Life Science Co., Ltd.
- Decided: May 28, 2024 after 245 days
- Product code: DPT (Probe, Blood-Flow, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K905232 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122943: Moorflpi-2 Full-Field Laser Perfusion Imager, Moor Instruments, Ltd. (2013) Summary page 5.

## Indications for use
The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use.

Source page: https://510kreport.com/device/K233076
Methodology: https://510kreport.com/methodology