neoBLUE Compact LED Phototherapy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160745 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 neoBLUE Compact LED Phototherapy System is a Class II medical device classified as a Neonatal Phototherapy Unit, designed to treat neonatal jaundice by delivering blue light therapy to newborns. It employs LED technology to safely and effectively reduce bilirubin levels in infants, reducing the risk of complications associated with hyperbilirubinemia. The system is engineered for use in both hospital and home care environments, ensuring accessibility for neonatal care settings.
This device is supplied as a reusable medical system, requiring proper cleaning and maintenance as per manufacturer guidelines. It is not intended for MRI use and must be stored in a clean, dry environment to preserve functionality. The system holds FDA 510(k) clearance (K160745) and complies with 21 CFR 880.5700, ensuring adherence to regulatory standards for neonatal phototherapy devices. No sterility claims are made, and its use is restricted to medical professionals trained in neonatal care.
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® Compact LED Phototherapy for Jaundice - Natus Sensory, neoBLUE® LED Phototherapy System - Natus Sensory, NATUS NEOBLUE COMPACT USER MANUAL Pdf Download | ManualsLib, NATUS NEOBLUE USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160745 | Class II | Active |
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Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA 510(k) K160745 24 fields · synced Sep 19, 2026