← Product Code [LBI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI) · K873700

# INSTITUTIONAL BILI LIGHT (IBL) (K873700)

_Physician Engineered Products, Inc. · LBI · Dec 11, 1987 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K873700

## Device Facts

- **Applicant:** Physician Engineered Products, Inc.
- **Product Code:** [LBI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI.md)
- **Decision Date:** Dec 11, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5700
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K873700](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K873700)

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