---
kind: "section"
citation: "21 C.F.R. § 880.5700"
title: "21"
number: "880.5700"
heading: "Neonatal phototherapy unit."
url: "https://uscodex.org/cfr/21/880.5700"
---

# §880.5700. Neonatal phototherapy unit.

- (a) **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.
- (b) **Classification.** Class II (performance standards).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.