The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or…
The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Bilisoft 2.0 | Listed by | Lumitex, Inc., United States |
| FDA product code | LBI |
| Device type | Unit, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| 510(k) | K053568 |
| Record published | 2018-11-15 |
| Record revised | 2026-01-26 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
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.