[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5700]

[Page 418]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 880_GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
     Subpart F_General Hospital and Personal Use Therapeutic Devices
 
Sec. 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).