Cleared Traditional

neoBLUE compact LED Phototherapy System

K160745 · Natus Medical Incorporated · General Hospital
Dec 2016
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K160745 is an FDA 510(k) clearance for the neoBLUE compact LED Phototherapy System, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Natus Medical Incorporated (Seattle, US). The FDA issued a Cleared decision on December 12, 2016, 269 days after receiving the submission on March 18, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.

Submission Details

510(k) Number K160745 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2016
Decision Date December 12, 2016
Days to Decision 269 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LBI — Unit, Neonatal Phototherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5700

Similar Devices — LBI Unit, Neonatal Phototherapy

All 70
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K251308 · Thera B Medical Products · Jan 2026
BiliWrap
K243372 · Gerium Medical, Ltd. · May 2025
Infant Phototherapy Equipment
K210289 · Bistos Co., Ltd. · May 2021
Neonatal Phototherapy System
K200031 · Avalon Biomedical (Shenzhen) Limited · Oct 2020
bili-hut
K190899 · Little Sparrows Technologies, Inc. · Sep 2019
neoBLUE blanket LED Phototherapy System
K182178 · Natus Medical Incorporated · Dec 2018