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Natus Blue Light Phototherapy Unit LBI

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022196

by Natus Medical, Inc.

Identifiers

510(k) Number
K022196 FDA 510(k)
FDA Product Code
LBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5700 FDA 510(k)
Regulation Number
880.5700 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Natus Blue Light Phototherapy Unit is a neonatal phototherapy device designed to treat hyperbilirubinemia in newborns by administering blue light therapy. It falls under the classification of a Neonatal Phototherapy Unit, which uses specific wavelengths of light to break down bilirubin in the bloodstream, reducing the risk of jaundice-related complications.

This device is intended for use in hospital settings and is supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K022196) and adheres to regulatory standards outlined in 880.5700. The unit is not single-use and requires proper maintenance and calibration to ensure safe and effective performance. No MRI safety information or specific sterility requirements are noted in the provided data.

Frequently asked questions

What is the primary clinical purpose of the Natus Blue Light Phototherapy Unit, and where is it typically used?

The Natus Blue Light Phototherapy Unit is designed to treat hyperbilirubinemia (jaundice) in newborns by administering blue light therapy. This process helps break down bilirubin in the bloodstream, reducing the risk of complications associated with jaundice. It is intended for use exclusively in hospital settings, particularly in neonatal care units.

Is the Natus Blue Light Phototherapy Unit a single-use or reusable device, and what maintenance is required?

The Natus Blue Light Phototherapy Unit is a reusable medical instrument. Since it is not single-use, it requires proper maintenance and regular calibration to ensure safe and effective performance. The manufacturer emphasizes adherence to these procedures to uphold the device’s functionality and reliability.

What regulatory pathway was followed for the FDA clearance of this device, and what classification does it fall under?

The Natus Blue Light Phototherapy Unit received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type. It is classified as a Class II device (device class=2) and falls under the Neonatal Phototherapy Unit category. The clearance was granted as substantially equivalent to a predicate device, adhering to regulatory standards outlined in 21 CFR 880.5700.

Are there any special storage or handling requirements for this device beyond standard medical equipment protocols?

The provided data does not specify any unique sterility requirements or special storage conditions beyond general medical equipment protocols. However, since it is reusable, it must be cleaned, maintained, and calibrated according to the manufacturer’s guidelines to ensure optimal performance and safety in clinical use.

What types of hospitals or medical facilities are most commonly registered to use this device?

The device is registered under the General Hospital medical specialty description, indicating it is most commonly used in general hospital settings, particularly those with neonatal intensive care units (NICUs) or pediatric wards. The registration numbers listed align with various hospital facilities, confirming its broad application in standard hospital environments.

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: neoBLUE® LED Phototherapy System - Natus Sensory, Natus Medical Incorporated, neoBLUE® nova LED phototherapy system - Natus Sensory, Natus Medical Incorporated, NATUS BLUE LIGHT PHOTOTHERAPY UNIT (K022196) — FDA 510(k) - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Natus Medical, Inc.

Sources (1)

  • FDA 510(k) K022196 24 fields · synced Sep 19, 2026