Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5700](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5700) → LBI — Unit, Neonatal Phototherapy # LBI · Unit, Neonatal Phototherapy _General Hospital · 21 CFR 880.5700 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI ## Overview - **Product Code:** LBI - **Device Name:** Unit, Neonatal Phototherapy - **Regulation:** [21 CFR 880.5700](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5700) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K251308.md) | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | Jan 15, 2026 | SESE | | [K243372](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K243372.md) | BiliWrap | Gerium Medical, Ltd. | May 29, 2025 | SESE | | [K210289](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K210289.md) | Infant Phototherapy Equipment | Bistos Co., Ltd. | May 28, 2021 | SESE | | [K200031](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K200031.md) | Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited | Oct 5, 2020 | SESE | | [K190899](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K190899.md) | bili-hut | Little Sparrows Technologies, Inc. | Sep 5, 2019 | SESE | | [K182178](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K182178.md) | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | Dec 13, 2018 | SESE | | [K172656](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K172656.md) | BiliLux | Draeger Medical Systems, Inc. | May 1, 2018 | SESE | | [K170585](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K170585.md) | Skylife | Neolight, LLC | Oct 27, 2017 | SESE | | [K163526](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K163526.md) | Bilicocoon™ Phototherapy System | Neomedlight | Oct 6, 2017 | SESE | | [K160745](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K160745.md) | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | Dec 12, 2016 | SESE | | [K160238](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K160238.md) | Airborne Phototherapy Light | International Biomedical | Jun 14, 2016 | SESE | | [K160305](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K160305.md) | neoBLUE® LED Phototherapy System | Natus Medical Incorporated | May 27, 2016 | SESE | | [K142332](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K142332.md) | BT-400 | Bio-Med USA | Mar 20, 2015 | SESE | | [K131196](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K131196.md) | INFANT PHOTOTHERAPY BILITRON SKY 5006 | Fanem Lda | Feb 20, 2014 | SESE | | [K120820](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K120820.md) | GIRAFFE BLUE SPOT PT LITE | Lumitex, Inc. | Jun 8, 2012 | SESE | | [K120168](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K120168.md) | LULLABY LED PHOTTHERAPY SYSTEM | Wipro GE Healthcare Private, Ltd. | May 2, 2012 | SESE | | [K111547](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K111547.md) | BILI-THERAPY PAD TYPE | Atom Medical Corporation | Apr 12, 2012 | SESE | | [K113206](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K113206.md) | NANOBLUTM 500 | Draeger Medical Systems, Inc. | Feb 17, 2012 | SESE | | [K110550](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K110550.md) | BRIGHT EMBRACE MODEL SBL60 | Physician Engineered Products, Inc. | Feb 3, 2012 | SESE | | [K103735](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI/K103735.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LBI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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