INSTITUTIONAL BILI LIGHT (IBL)
Device Facts
| Record ID | K873700 |
|---|---|
| Device Name | INSTITUTIONAL BILI LIGHT (IBL) |
| Applicant | Physician Engineered Products, Inc. |
| Product Code | LBI · General Hospital |
| Decision Date | Dec 11, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.
