21 CFR § 880.5700 - Neonatal phototherapy unit.

---
identifier: "/us/cfr/t21/s880.5700"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.5700 - Neonatal phototherapy unit."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.5700"
section_name: "Neonatal phototherapy unit."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 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).