Airborne Phototherapy Light
The Airborne Observation and Phototherapy Light uses blue LEDs to treat neonatal hyperbilirubinemia, commonly called newborn jaundice. It is designed for infants in incubators, with the…
The Airborne Observation and Phototherapy Light uses blue LEDs to treat neonatal hyperbilirubinemia, commonly called newborn jaundice. It is designed for infants in incubators, with the light mounted on the incubator hood.
The same unit also has white LEDs for observation. Its observation mode supplements the surrounding room lighting, while its separate blue light mode provides phototherapy. The device therefore combines treatment illumination and auxiliary viewing light in one assembly.
Listed Item
LED Phototherapy Light Bar
Use Setting
The light is intended for hospital or institutional use with neonatal patients. It delivers light without a direct patient connection. The blue LED phototherapy output is specified within a wavelength range of 400 to 500 nanometers.
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 | International Biomedical, Ltd., United States |
|---|---|
| FDA product code | LBI |
| Device type | Unit, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K160238 |
| Record published | 2016-09-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 731-0209 | 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 |
|---|---|
| K160238 | 2016-06-14 |
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.