Skylife Lightbed
Skylife is a portable phototherapy light bed for treating unconjugated hyperbilirubinemia in newborns. It delivers blue light from beneath the baby and must be used inside an enclosure such…
Skylife is a portable phototherapy light bed for treating unconjugated hyperbilirubinemia in newborns. It delivers blue light from beneath the baby and must be used inside an enclosure such as a bassinet, crib, warming table or incubator.
Blue LEDs emit light between 430 and 475 nm, corresponding to bilirubin’s light absorption range. A controller provides low, high and very high intensity settings, with the caregiver selecting the level prescribed by the physician.
Listed Item
Phototherapy Device
Bed Components and Settings
The system includes the light bed and modules, a gel mat, a disposable mattress cover, a controller and a power supply. Low intensity is 25 to 35 µW/cm²/nm, high is 35 to 55, and very high exceeds 55. It can be used at home or in clinical settings.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Neolight, LLC, United States |
|---|---|
| FDA product code | LBI |
| Device type | Unit, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K170585 |
| Record published | 2018-11-09 |
| Record revised | 2024-02-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NL-SK-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| bili-hut™ | Little Sparrows Technologies Inc | 33 |
| NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 10 |
| neoBLUE | Natus Medical Incorporated | 9 |
| Bilisoft 2.0 | Lumitex, Inc. | 4 |
| BiliSoft Phototherapy System | Datex-Ohmeda, Inc. | 3 |
| Lamp | RPI | 3 |
| Giraffe Blue Spot PT Lite | Datex-Ohmeda, Inc. | 2 |
| BiliCocoon™ Nest System | Neomedlight | 2 |
| BiliCocoon™ Bag System | Neomedlight | 2 |
| BiliCocoon™ Nest Disposable | Neomedlight | 2 |
| Unit, Neonatal Phototherapy | Bistos Co., Ltd. | 2 |
| BiliCocoon™ Bag Pad | Neomedlight | 2 |
Showing 12 of 61. All products under Unit, Neonatal Phototherapy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170585 | 2017-10-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.