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BiliLux Neonatal Phototherapy Unit

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K172656

by Draeger Medical Systems, Inc.

Identifiers

510(k) Number
K172656 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 BiliLux is a Neonatal Phototherapy Unit, designed for the treatment of neonatal jaundice by delivering controlled light therapy to infants. It emits specific wavelengths of light to break down bilirubin, a substance that causes jaundice, thereby reducing its levels in the bloodstream and preventing potential complications such as kernicterus.

This device is intended for use in neonatal intensive care units (NICUs) and general hospital settings. Supplied as a reusable medical device, it requires proper sterilisation and maintenance as per manufacturer guidelines. The BiliLux complies with FDA 510(k) clearance and the Medical Device Directive (MDD), ensuring adherence to regulatory standards for neonatal phototherapy units. Multiple model references are available, including LBI, and it operates within the scope of regulation number 880.5700.

Frequently asked questions

What clinical setting is the BiliLux designed for, and how does it address neonatal jaundice?

The BiliLux is specifically designed for use in neonatal intensive care units (NICUs) and general hospital settings. It delivers controlled light therapy to treat neonatal jaundice by emitting targeted wavelengths that break down bilirubin—a substance responsible for jaundice—in infants. This helps reduce bilirubin levels in the bloodstream, lowering the risk of complications like kernicterus.

Is the BiliLux a single-use or reusable device, and what maintenance is required?

The BiliLux is a reusable medical device, meaning it is intended for repeated use in clinical settings. Like all reusable devices, it requires proper sterilization and maintenance as outlined in the manufacturer’s guidelines to ensure safety and performance.

What regulatory pathways does the BiliLux follow, and which models are available?

The BiliLux complies with FDA 510(k) clearance (K172656) and the Medical Device Directive (MDD). Multiple model references are available, including the LBI model, which falls under product code category LBI and regulation number 880.5700.

How does the BiliLux differ from other neonatal phototherapy units in terms of regulatory classification?

The BiliLux is classified as a Class II medical device under FDA regulations, indicated by its 510(k) clearance and the General Hospital advisory committee designation. This classification reflects its intended use for controlled light therapy in neonatal settings, ensuring it meets stringent regulatory standards for safety and effectiveness.

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
Draeger Medical Systems, Inc.

Sources (2)

  • FDA 510(k) K172656 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026