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Laser Speckle Imaging System (RFLSI CZW)

by RWD Life Science Co., Ltd. China 510(k)

510(k) K233076 Product code DPT

Overview

The Laser Speckle Imaging System (RFLSI CZW) is a non-invasive, extravascular blood-flow probe classified under Probe, Blood-Flow, Extravascular (OpenFDA: 3013500228). It employs Laser Speckle Contrast Imaging (LSCI) technology to measure microcirculatory blood flow in human and animal tissues, providing high-resolution, real-time imaging without physical contact.

This system is intended for clinical research use and is supplied as a reusable medical device. It operates under FDA 510(k) clearance (K233076) with a Substantially Equivalent determination by the Cardiovascular Advisory Committee. The device is designed for use in cardiovascular research settings, adhering to regulatory standards outlined in 21 CFR 870.2120. No sterility or single-use specifications are indicated in the provided data.

Summary written by AI from registry data, 20 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233076 Date28 May 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
DPT
Device Class
Class II
Regulation
21 CFR Part 870.2120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary clinical application of the Laser Speckle Imaging System (RFLSI CZW) and how does it differ from traditional blood-flow measurement methods?

    The Laser Speckle Imaging System (RFLSI CZW) is designed for clinical research use in cardiovascular settings, specifically to measure microcirculatory blood flow in human and animal tissues. Unlike traditional methods that may require invasive probes or contact-based sensors, this system uses Laser Speckle Contrast Imaging (LSCI) technology to provide non-invasive, real-time, high-resolution imaging without physical contact. This allows for dynamic monitoring of blood flow in tissues without disrupting the measurement environment.

  • Is the Laser Speckle Imaging System (RFLSI CZW) intended for single-use or reusable applications, and what does this mean for maintenance?

    The Laser Speckle Imaging System (RFLSI CZW) is explicitly described as a reusable medical device. This means it is designed for repeated use across multiple procedures or studies, provided it undergoes proper cleaning, disinfection, and maintenance as per manufacturer guidelines. Reusability can reduce costs over time but requires adherence to sterile processing protocols to ensure safety and performance consistency.

  • What regulatory pathway was followed for FDA clearance of the Laser Speckle Imaging System (RFLSI CZW), and how does this affect its use in research?

    The Laser Speckle Imaging System (RFLSI CZW) received FDA 510(k) clearance (K233076) with a Substantially Equivalent (SESE) determination by the Cardiovascular Advisory Committee. This clearance confirms the device meets regulatory standards for Probe, Blood-Flow, Extravascular applications under 21 CFR 870.2120, making it suitable for clinical research use in cardiovascular studies. The clearance does not imply routine clinical use but validates its safety and performance for research purposes.

  • Does the Laser Speckle Imaging System (RFLSI CZW) require any special storage conditions, and what should researchers consider when handling it?

    The provided data does not specify sterility requirements or special storage conditions for the Laser Speckle Imaging System (RFLSI CZW). However, as a reusable device, researchers should follow standard cleaning, disinfection, and storage protocols to prevent contamination and ensure optimal performance. Environmental factors like temperature and humidity may still influence longevity, so adherence to manufacturer recommendations (if available) is advised.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K233076 24 fields · synced 22 Oct 2026