# Skylife

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/skylife-lbi>
- Manufacturer: [Neolight LLC](https://devicerts.com/manufacturers/neolight-llc) (United States, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: LBI

## Overview

*AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K170585 · decision 2017-10-27 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K170585 [FDA 510(k)]
- FDA product code: LBI [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 880.5700 [FDA 510(k)]
- Advisory committee: General Hospital [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Skylife, Neolight LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/skylife-lbi (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/skylife-lbi.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/skylife-lbi
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.