This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the…
This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home. The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for BiliTouchTM | Listed by | Bistos Co., Ltd., South Korea |
| FDA product code | LBI |
| Device type | Unit, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K210289 |
| Record published | 2021-06-09 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Carton box of 8 |
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.