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Precious Lite Model 4224

by E & B Technologies, Inc. 510(k)

Active United States

510(k) K892940

Overview

The Precious Lite Model 4224 is a neonatal phototherapy unit, classified as a Unit, Neonatal Phototherapy device. It emits therapeutic light to degrade bilirubin in newborns, thereby treating neonatal jaundice and reducing associated risks.

This reusable device is intended for use in general hospital neonatal care settings. It holds an FDA 510(k) clearance (K892940) under regulation 880.5700, confirming substantial equivalence. No specific sterility, MRI safety, or additional storage instructions are provided in the data.

Precious Lite Model 4224

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK892940 Date3 Aug 1989ClearedStatusActive

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 5 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

Other devices from E & B Technologies, Inc.

Questions

  • What is the Precious Lite Model 4224 used for?

    The Precious Lite Model 4224 is a neonatal phototherapy unit designed to emit therapeutic light that helps degrade bilirubin in newborns. This treatment is specifically for managing neonatal jaundice, a common condition where excess bilirubin builds up in a baby’s bloodstream, potentially causing complications if untreated.

  • Is the Precious Lite Model 4224 reusable or single-use?

    The Precious Lite Model 4224 is a reusable device. It is intended for use in general hospital neonatal care settings and is not designed for single-use applications. Proper cleaning and maintenance are required to ensure its continued effectiveness and safety.

  • What regulatory clearance does the Precious Lite Model 4224 hold?

    The Precious Lite Model 4224 holds an FDA 510(k) clearance (K892940) under regulation 880.5700. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets FDA requirements for safety and effectiveness.

  • Are there any specific storage instructions for the Precious Lite Model 4224?

    The provided data does not specify any additional storage instructions for the Precious Lite Model 4224 beyond standard hospital protocols for reusable medical devices. It is recommended to follow manufacturer guidelines for optimal performance and longevity.

  • What types of hospitals or settings is the Precious Lite Model 4224 intended for?

    The Precious Lite Model 4224 is intended for use in general hospital neonatal care settings. Its design and clearance align with the needs of standard hospital environments where newborns may require phototherapy for jaundice management.