Product code LBI
- Device name
- Unit, Neonatal Phototherapy
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5700
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | 2026-01-15 |
| K243372 | BiliWrap | Gerium Medical, Ltd. | 2025-05-29 |
| K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021-05-28 |
| K200031 | Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited | 2020-10-05 |
| K190899 | bili-hut | Little Sparrows Technologies, Inc. | 2019-09-05 |
| K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | 2018-12-13 |
| K172656 | BiliLux | Draeger Medical Systems, Inc. | 2018-05-01 |
| K170585 | Skylife | Neolight, LLC | 2017-10-27 |
| K163526 | Bilicocoon™ Phototherapy System | Neomedlight | 2017-10-06 |
| K160745 | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | 2016-12-12 |
| K160238 | Airborne Phototherapy Light | International Biomedical | 2016-06-14 |
| K160305 | neoBLUE® LED Phototherapy System | Natus Medical Incorporated | 2016-05-27 |
| K142332 | BT-400 | Bio-Med USA | 2015-03-20 |
| K131196 | INFANT PHOTOTHERAPY BILITRON SKY 5006 | Fanem Lda | 2014-02-20 |
| K120820 | GIRAFFE BLUE SPOT PT LITE | Lumitex, Inc. | 2012-06-08 |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | Wipro GE Healthcare Private, Ltd. | 2012-05-02 |
| K111547 | BILI-THERAPY PAD TYPE | Atom Medical Corporation | 2012-04-12 |
| K113206 | NANOBLUTM 500 | Draeger Medical Systems, Inc. | 2012-02-17 |
| K110550 | BRIGHT EMBRACE MODEL SBL60 | Physician Engineered Products, Inc. | 2012-02-03 |
| K103735 | MEDILED MINI | Medix I.C.S.A. | 2011-08-15 |
| K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | Natus Medical Incorporated | 2011-05-13 |
| K103828 | BILI-THERAPY SPOT TYPE | Atom Medical Corporation | 2011-03-29 |
| K093618 | BILI-MIRROR MODEL BLM-1 | Physician Engineered Products, Inc. | 2010-04-23 |
| K090192 | BILI BLUE F20T12/BBY AND F40T12/BBY | Interlectric Corp. | 2009-04-24 |
| K083179 | MEDILED PHOTOTHERAPY LAMP | Medix I.C.S.A. | 2009-02-27 |
| K072097 | BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 | Medical Select, Inc. | 2007-10-30 |
| K071828 | LULLABY | Ge Healthcare Clinical Systems | 2007-08-06 |
| K070180 | WALLABY 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007-05-18 |
| K053568 | BILISOFT PHOTOTHERAPY SYSTEM | Lumitex, Inc. | 2006-04-17 |
| K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | Natus Medical, Inc. | 2005-10-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03760012570249 | BiliCocoon™ Bag Pad | NEOMEDLIGHT | 2026-04-27 |
| 03760012570225 | BiliCocoon™ Service Kit | NEOMEDLIGHT | 2026-04-27 |
| 03760012570218 | BiliCocoon™ Fixation System | NEOMEDLIGHT | 2026-04-27 |
| 03760012570195 | BiliCocoon™ Nest Disposable | NEOMEDLIGHT | 2026-04-27 |
| 03760012570188 | BiliCocoon™ Nest Pad | NEOMEDLIGHT | 2026-04-27 |
| 03760012570102 | BiliCocoon™ Light Box | NEOMEDLIGHT | 2026-04-27 |
| 03760012570126 | BiliCocoon™ Bag System | NEOMEDLIGHT | 2026-04-27 |
| 03760012570133 | BiliCocoon™ Bag Disposable | NEOMEDLIGHT | 2026-04-27 |
| 03760012570171 | BiliCocoon™ Nest System | NEOMEDLIGHT | 2026-04-27 |
| 05713315011252 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011863 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011269 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011276 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011283 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011313 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011351 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011405 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011849 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011856 | NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 2026-01-22 |
| 05713315011221 | Neoblue | Natus Medical Denmark ApS | 2025-05-27 |
| 05713315011214 | NeoBLUE Nova | Natus Medical Denmark ApS | 2025-05-27 |
| 08800012345012 | BiliTouchTM | Bistos Co., Ltd. | 2021-06-09 |
| 08800012345005 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021-06-08 |
| 10852788008054 | Light Module | NEOLIGHT LLC | 2018-11-09 |
| 03760012570089 | BiliCocoon™ Bag Disposable | NEOMEDLIGHT | 2017-11-03 |
| 03760012570041 | BiliCocoon™ Nest Disposable | NEOMEDLIGHT | 2017-11-03 |
| 00020451384023 | Bilibed | Medela AG | 2016-09-23 |
| 00887529000182 | N/A | Bistos Co., Ltd. | 2016-06-03 |
| 00887529000113 | N/A | Bistos Co., Ltd. | 2016-06-03 |
| 04048675041689 | Photo-Therapy 4000 | Drägerwerk AG & Co. KGaA | 2015-10-24 |