Skylife
by Neolight LLC
510(k) K170585
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170585 | Date27 Oct 2017 | StatusActive |
Official records
- FDA 510(k) database K170585
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LBI
- FDA applicant
- Neolight, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5700
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
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.
Devices cleared under K170585
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Cloud Swaddle NL-SK-5 | NL-SK-5 | 10852788008092 | No longer on the market | |
| CloudCover NL-SK-5S | NL-SK-5S / NL-SK-5S | 10852788008177 | On the market | |
| CloudCover Plus NL-SK-8S | NL-SK-8S / NL-SK-8S | 10852788008047 | On the market | |
| GelMat Consumable NL-SK-2-212 | NL-SK-6 / NL-SK-2-212 | 10852788008122 | On the market | |
| GelMat NL-SK-2-212 | NL-SK-2-212 | 10852788008023 | On the market | |
| Light Module NL-SK-3 | NL-SK-3 | 10852788008054 | On the market | |
| Skylife Controller NL-SK-1 | NL-SK-1 | 10852788008016 | On the market | |
| Skylife Lightbed NL-SK-2 | NL-SK-2 | 10852788008009 | On the market | |
| Skylife System NL-SK | NL-SK | 10852788008078 | On the market |
Similar devices
Other devices filed under FDA product code LBI (Unit, Neonatal Phototherapy).
- RETROFIT BABY FACE SHIELD (RFS) by Physician Engineered Products, Inc.
- Bili-Therapy Spot Type by Atom Medical Corporation
- DRAGER PT4000 PHOTOTHERAPY SYSTEM by Drager, Inc.
- BILI-THERAPY Spot Type / Stand Type AC100-240V 60360 by Atom Medical Corporation
- AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM by Air-Shields Vickers, Inc.
- MODEL 533 PHOTOTHERAPY UNIT by Narco Air-Shields
- BRIGHT EMBRACE MODEL SBL60 by Physician Engineered Products, Inc.
- BILIBLANKET PLUS PHOTOTHERAPY SYSTEM by Boc Health Care, Inc.
- NEOBLUE COZY LED PHOTOTHERAPY SYSTEM by Natus Medical, Inc.
- BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 by Medical Select, Inc.