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Lightmed Ultrasound System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183173

by Lightmed USA, Inc.

Identifiers

510(k) Number
K183173 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lightmed Ultrasound System is a Class II medical device classified as a System, Imaging, Pulsed Echo, Ultrasonic (product code IYO). It functions as a diagnostic imaging tool that uses high-frequency sound waves to visualize internal body structures, aiding in the assessment of organs, tissues, and blood flow for clinical evaluation.

This system is supplied by Lightmed USA, Inc. and is intended for use in radiology settings. It is cleared for single-use or reusable applications as determined by facility protocols, with regulatory approval granted under FDA 510(k) clearance (K183173) following a review by the Radiology (RA) Advisory Committee. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What clinical environments is the Lightmed Ultrasound System designed for and how does its classification support its use there?

The Lightmed Ultrasound System is specifically designed for radiology settings, where diagnostic imaging is performed. Its classification as a Class II medical device under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic) confirms it is intended for creating detailed images of internal body structures using high-frequency sound waves. This classification aligns with its role in visualizing organs, tissues, and blood flow for clinical evaluation, making it suitable for environments where real-time diagnostic imaging is essential.

Is the Lightmed Ultrasound System intended for single-use or reusable applications, and what determines its usage in a clinical setting?

The Lightmed Ultrasound System itself is not explicitly designated as single-use or reusable in the provided data. Instead, its usage is determined by facility protocols, meaning each healthcare facility decides whether to use it as a single-use or reusable device based on their infection control and operational policies. This flexibility allows for customization to meet specific clinical needs and regulatory requirements.

How was the FDA clearance for the Lightmed Ultrasound System obtained, and what does the advisory committee involvement signify?

The Lightmed Ultrasound System received FDA clearance through a traditional 510(k) review process, specifically under clearance number K183173. The device was deemed *substantially equivalent* to a legally marketed predicate, meaning it was evaluated by the FDA’s Radiology (RA) Advisory Committee to ensure it met the same performance and safety standards. The involvement of the RA Advisory Committee signifies that the device’s design and intended use were carefully reviewed by experts in radiology to confirm its suitability for diagnostic imaging purposes.

What key details about the manufacturer and regulatory submission process for the Lightmed Ultrasound System should buyers or clinicians know?

The Lightmed Ultrasound System is manufactured by Lightmed USA, Inc., headquartered at 1130 Calle Cordillera, San Clemente, CA 92673. The device was submitted to the FDA on November 16, 2018, and cleared on July 1, 2019, after review by the Radiology Advisory Committee. Buyers or clinicians should note that the submission was filed under the traditional 510(k) pathway, with no third-party involvement (third_party_flag: N), and that the clearance was based on a determination of substantial equivalence to a predicate device.

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. Sources consulted: Lightmed Ultrasound - allmed.wiki, LIGHTMED, K183173 - LIGHTMED Ultrasound System | FDA 510 (k), LIGHTMED Ultrasound System (K183173) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lightmed USA, Inc.

Sources (1)

  • FDA 510(k) K183173 24 fields · synced Sep 19, 2026