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Moorldls-Bi Laser Doppler Burns Imager

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132163

by Moor Instruments Ltd

Identifiers

510(k) Number
K132163 FDA 510(k)
FDA Product Code
DPT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2120 FDA 510(k)
Regulation Number
870.2120 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MoorDLS-BI Laser Doppler Burns Imager is a non-invasive diagnostic device classified as a Probe, Blood-Flow, Extravascular. It utilises laser Doppler technology to assess microcirculatory blood flow in burn wounds, enabling objective evaluation of tissue perfusion and healing progress. This aids clinicians in determining wound severity and guiding therapeutic interventions.

The device is supplied as a reusable medical instrument and is intended for use in clinical settings such as burn units or emergency departments. It operates under sterile conditions when applied to patients and is classified as a Class II medical device under FDA regulations. The MoorDLS-BI is authorised for use in the United States via FDA 510(k) clearance (K132163) and complies with the European Medical Device Directive (MDD)

Manufacturer's product page: High Resolution Laser Doppler Imager

Frequently asked questions

What clinical setting is the MoorDLS-BI Laser Doppler Burns Imager primarily designed for, and how does it assist clinicians in their work?

The MoorDLS-BI is specifically designed for use in clinical settings like burn units or emergency departments. It employs laser Doppler technology to non-invasively assess microcirculatory blood flow in burn wounds, helping clinicians objectively evaluate tissue perfusion and monitor healing progress. This aids in determining wound severity and guides therapeutic decisions, such as when to intervene or adjust treatment plans.

Is the MoorDLS-BI a single-use or reusable device, and what does this mean for its use in a clinical environment?

The MoorDLS-BI is a reusable medical instrument, meaning it is intended for repeated use in clinical settings after proper cleaning, sterilization, and maintenance. This design allows for consistent performance across multiple patients while adhering to sterile conditions during patient application, ensuring reliability in burn units or emergency departments.

What regulatory pathways has the MoorDLS-BI followed for approval in the United States and Europe?

In the United States, the MoorDLS-BI received FDA 510(k) clearance (K132163) through a traditional review process, determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulations. Internationally, it complies with the European Medical Device Directive (MDD), ensuring its authorization for use in the European market.

How does the MoorDLS-BI differ from other diagnostic tools used in burn wound assessment?

Unlike traditional visual or subjective assessments of burn wounds, the MoorDLS-BI uses laser Doppler technology to objectively measure microcirculatory blood flow in tissue. This provides quantitative data on perfusion and healing progress, which can help clinicians distinguish between superficial and deeper burns more accurately than visual inspection alone. The device’s non-invasive nature also reduces patient discomfort compared to invasive methods.

What types of burn wounds is the MoorDLS-BI intended to evaluate, and why is blood flow assessment important in this context?

The MoorDLS-BI is intended to evaluate burn wounds by assessing microcirculatory blood flow, which is critical for determining tissue viability and healing potential. Adequate blood flow ensures oxygen and nutrient delivery to damaged tissue, while impaired perfusion may indicate deeper burns or complications like necrosis. By quantifying perfusion, clinicians can better assess wound severity and tailor interventions like debridement or grafting.

This description and any FAQs above were generated automatically from registry data 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Moor Instruments Ltd
FDA Applicant
Moor Instruments, Ltd.

Sources (2)

  • FDA 510(k) K132163 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026