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Neonatal Phototherapy System

by Avalon Biomedical (Shenzhen) Limited 510(k)

Active United States

510(k) K200031

Overview

The Neonatal Phototherapy System KANGALITE is a medical device classified as a neonatal phototherapy unit, designed for the treatment of unconjugated hyperbilirubinemia in neonates with a gestational age of at least 38 weeks and a weight variation of within 2 grams. It employs phototherapy to break down excess bilirubin in newborns, reducing the risk of jaundice-related complications.

This system is supplied as a reusable medical device and is intended for use in general hospital settings. It has received FDA 510(k) clearance under product code LBI, adhering to Class II regulatory standards. The device is not specified as sterile but is intended for clinical use in controlled environments, with no explicit mention of MRI safety or specific storage requirements in the provided data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200031 Date5 Oct 2020ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LBI
Device Class
Class II
Regulation
21 CFR Part 880.5700
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Questions

  • What types of neonatal patients is the Neonatal Phototherapy System KANGALITE specifically designed to treat?

    The system is designed for neonates with a gestational age of at least 38 weeks and a weight variation within 2 grams, targeting unconjugated hyperbilirubinemia to reduce jaundice-related complications.

  • Is the Neonatal Phototherapy System KANGALITE intended for single-use or reusable applications in clinical settings?

    The device is explicitly described as a reusable medical device, intended for use in general hospital environments rather than disposable applications.

  • What regulatory pathway did the Neonatal Phototherapy System KANGALITE follow to gain market authorization in the U.S.?

    The system received FDA 510(k) clearance under product code LBI, adhering to Class II regulatory standards, with a decision date of October 5, 2020, and a traditional review process.

  • Does the Neonatal Phototherapy System KANGALITE require sterile handling, or is it intended for use in non-sterile environments?

    The device is not specified as sterile, but it is intended for clinical use in controlled hospital environments where standard infection control practices are followed.

  • What is the primary clinical purpose of the Neonatal Phototherapy System KANGALITE, and how does it achieve its intended effect?

    The system employs phototherapy to break down excess bilirubin in newborns, specifically targeting unconjugated hyperbilirubinemia to lower bilirubin levels and reduce the risk of jaundice-related complications in neonates.