LBI · Unit, Neonatal Phototherapy
General Hospital · 21 CFR 880.5700 · Class 2
Overview
| Product Code | LBI |
|---|---|
| Device Name | Unit, Neonatal Phototherapy |
| Regulation | 21 CFR 880.5700 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | Jan 15, 2026 | SESE |
| K243372 | BiliWrap | Gerium Medical, Ltd. | May 29, 2025 | SESE |
| K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | May 28, 2021 | SESE |
| K200031 | Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited | Oct 5, 2020 | SESE |
| K190899 | bili-hut | Little Sparrows Technologies, Inc. | Sep 5, 2019 | SESE |
| K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | Dec 13, 2018 | SESE |
| K172656 | BiliLux | Draeger Medical Systems, Inc. | May 1, 2018 | SESE |
| K170585 | Skylife | Neolight, LLC | Oct 27, 2017 | SESE |
| K163526 | Bilicocoon Phototherapy System | Neomedlight | Oct 6, 2017 | SESE |
| K160745 | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | Dec 12, 2016 | SESE |
| K160238 | Airborne Phototherapy Light | International Biomedical | Jun 14, 2016 | SESE |
| K160305 | neoBLUE® LED Phototherapy System | Natus Medical Incorporated | May 27, 2016 | SESE |
| K142332 | BT-400 | Bio-Med USA | Mar 20, 2015 | SESE |
| K131196 | INFANT PHOTOTHERAPY BILITRON SKY 5006 | Fanem Lda | Feb 20, 2014 | SESE |
| K120820 | GIRAFFE BLUE SPOT PT LITE | Lumitex, Inc. | Jun 8, 2012 | SESE |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | Wipro GE Healthcare Private, Ltd. | May 2, 2012 | SESE |
| K111547 | BILI-THERAPY PAD TYPE | Atom Medical Corporation | Apr 12, 2012 | SESE |
| K113206 | NANOBLUTM 500 | Draeger Medical Systems, Inc. | Feb 17, 2012 | SESE |
| K110550 | BRIGHT EMBRACE MODEL SBL60 | Physician Engineered Products, Inc. | Feb 3, 2012 | SESE |
| K103735 | MEDILED MINI | Medix I.C.S.A. | Aug 15, 2011 | SESE |
Top Applicants
- Olympic Medical Corp. — 6 clearances
- Physician Engineered Products, Inc. — 6 clearances
- Natus Medical Incorporated — 4 clearances
- Air-Shields, Inc. — 3 clearances
- Medix I.C.S.A. — 3 clearances
