Identifiers
- 510(k) Number
- K170585 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 Skylife is a neonatal phototherapy system designed for the treatment of newborns with elevated bilirubin levels. It delivers phototherapy light to reduce indirect hyperbilirubinemia in infants, providing a non-invasive therapeutic option in clinical settings.
The device is intended for use in hospital and neonatal care environments under medical supervision. It is supplied as a complete phototherapy system and is regulated under FDA 510(k) authorization with product code LBI. The system is designed for single-patient use and should be operated in accordance with the manufacturer's user manual. Storage and handling instructions are detailed in the service and user documentation provided by NeoLight, LLC.
Frequently asked questions
What is the Skylife device intended to treat?
The Skylife is a neonatal phototherapy system designed to treat newborns with elevated bilirubin levels by delivering light therapy to reduce indirect hyperbilirubinemia. It is intended for use in hospital and neonatal care environments under medical supervision as a non-invasive therapeutic option.
Is the Skylife device supplied as a complete system?
Yes, the Skylife is supplied as a complete phototherapy system, meaning it arrives ready for clinical use with all necessary components included for operation in accordance with the manufacturer's user manual.
Is the Skylife device intended for single-patient or multiple-patient use?
The Skylife is designed for single-patient use, meaning it is intended to be used on one infant and should not be reused on another patient to ensure safety and hygiene.
Where should the Skylife device be stored before and after use?
Storage and handling instructions for the Skylife are detailed in the service and user documentation provided by NeoLight, LLC. Users should refer to these materials to ensure proper storage conditions are maintained before and after use.
What regulatory authorization does the Skylife device have?
The Skylife device is regulated under FDA 510(k) authorization with product code LBI, and its regulatory status is documented through this clearance pathway, indicating it has been reviewed for substantial equivalence to existing devices.
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: Skylife Neonatal Phototherapy System - theneolight.com, NeoLight Newborn Care, NEOLIGHT SKYLIFE USER MANUAL Pdf Download | ManualsLib, PDF Skylife Infant Phototherapy System Service Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170585 | Class II | Active |
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Manufacturer
- Manufacturer
- Neolight Llc
- FDA Applicant
- Neolight, LLC
Sources (1)
- FDA 510(k) K170585 24 fields · synced Sep 19, 2026