Unit, Neonatal Phototherapy
FDA product code LBI · Class II (moderate risk) · 21 CFR 880.5700 · General Hospital
71510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Physician Engineered Products, Inc. 6
- Natus Medical Incorporated 6
- Olympic Medical Corp. 6
- Medix I.C.S.A. 3
- Ohmeda Medical 3
- Air-Shields, Inc. 3
- Draeger Medical Systems, Inc. 2
- Medela AG 2
- Lumitex, Inc. 2
- Atom Medical Corporation 2
- E & B Technologies, Inc. 2
- Rocky Mountain Medical Corp. 2
- Aequitron Medical, Inc. 1
- Fiberoptic Medical Products, Inc. 1
- Thera B Medical Products 1
- Egnell, Inc. 1
- Dynatech Corp. 1
- Boc Health Care, Inc. 1
- Montrose Phototherapy Supply 1
- Narco Air-Shields 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)LBI · Traditional | Thera B Medical Products | 01/15/2026SE |
| K243372 | BiliWrapLBI · Traditional | Gerium Medical, Ltd. | 05/29/2025SE |
| K210289 | Infant Phototherapy EquipmentLBI · Traditional | Bistos Co., Ltd. | 05/28/2021SE |
| K200031 | Neonatal Phototherapy SystemLBI · Traditional | Avalon Biomedical (Shenzhen) Limited | 10/05/2020SE |
| K190899 | bili-hutLBI · Traditional | Little Sparrows Technologies, Inc. | 09/05/2019SE |
| K182178 | neoBLUE blanket LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/13/2018SE |
| K172656 | BiliLuxLBI · Traditional | Draeger Medical Systems, Inc. | 05/01/2018SE |
| K170585 | SkylifeLBI · Traditional | Neolight, LLC | 10/27/2017SE |
| K163526 | Bilicocoon Phototherapy SystemLBI · Traditional | Neomedlight | 10/06/2017SE |
| K160745 | neoBLUE compact LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/12/2016SE |
| K160238 | Airborne Phototherapy LightLBI · Abbreviated | International Biomedical | 06/14/2016SE |
| K160305 | neoBLUE® LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 05/27/2016SE |
| K142332 | BT-400LBI · Traditional | Bio-Med USA | 03/20/2015SE |
| K131196 | Infant Phototherapy Bilitron Sky 5006LBI · Traditional | Fanem Lda | 02/20/2014SE |
| K120820 | Giraffe Blue Spot PT LiteLBI · Traditional | Lumitex, Inc. | 06/08/2012SE |
| K120168 | Lullaby LED Phottherapy SystemLBI · Traditional | Wipro GE Healthcare Private, Ltd. | 05/02/2012SE |
| K111547 | Bili-Therapy Pad TypeLBI · Traditional | Atom Medical Corporation | 04/12/2012SE |
| K113206 | Nanoblutm 500LBI · Traditional | Draeger Medical Systems, Inc. | 02/17/2012SE |
| K110550 | Bright Embrace Model SBL60LBI · Traditional | Physician Engineered Products, Inc. | 02/03/2012SE |
| K103735 | Mediled MiniLBI · Traditional | Medix I.C.S.A. | 08/15/2011SE |
| K103589 | Neoblue Blanket LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 05/13/2011SE |
| K103828 | Bili-Therapy Spot TypeLBI · Traditional | Atom Medical Corporation | 03/29/2011SE |
| K093618 | Bili-Mirror Model BLM-1LBI · Traditional | Physician Engineered Products, Inc. | 04/23/2010SE |
| K090192 | Bili Blue F20T12/BBY and F40T12/BBYLBI · Traditional | Interlectric Corp. | 04/24/2009SE |
| K083179 | Mediled Phototherapy LampLBI · Traditional | Medix I.C.S.A. | 02/27/2009SE |
| K072097 | Bilibee LED Phototherapy System, Model: 1LBI · Traditional | Medical Select, Inc. | 10/30/2007SE |
| K071828 | LullabyLBI · Traditional | Ge Healthcare Clinical Systems | 08/06/2007SE |
| K070180 | Wallaby 4LBI · Traditional | Respironics Inc., Sleep & Home Respiratory Group | 05/18/2007SE |
| K053568 | Bilisoft Phototherapy SystemLBI · Traditional | Lumitex, Inc. | 04/17/2006SE |
| K051869 | Neoblue Cozy LED Phototherapy SystemLBI · Traditional | Natus Medical, Inc. | 10/07/2005SE |
| K040853 | Phoenix Phototherapy Unit CFL, Model 101LBI · Traditional | International Hospital Supply Co. | 06/21/2004SE |
| K022196 | Natus Blue Light Phototherapy UnitLBI · Traditional | Natus Medical, Inc. | 09/19/2002SE |
| K021531 | Rpi Replacement Phototherapy LightsLBI · Traditional | Replacement Parts Industries, Inc. | 05/31/2002SE |
| K011549 | Ohmeda Medical Spot PT Lite Phototherapy SystemLBI · Traditional | Ohmeda Medical | 07/19/2001SE |
| K010495 | Centura Phototherapy SpotlightLBI · Traditional | Medical Illumination International, Inc. | 03/09/2001SE |
| K002414 | Phototherapy Lamp 900IW501JE Phototherapy Power Module 900IW502JELBI · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/25/2000SE |
| K991627 | Wallaby 3 Phototherapy System, Model 3600LBI · Special | Respironics, Inc. | 05/17/1999SE |
| K984589 | Phototherapy LampLBI · Traditional | Medela, Inc. | 04/20/1999SE |
| K974830 | Ultra Bili LightLBI · Traditional | Physician Engineered Products, Inc. | 05/20/1998SE |
| K971601 | Olympic Bili-BassinetLBI · Traditional | Olympic Medical Corp. | 09/24/1997SE |
| K971256 | Duo-Lite Phototherapy SystemLBI · Traditional | Air-Shields, Inc. | 09/24/1997SE |
| K962612 | Bilibed Phototherapy LampLBI · Traditional | Medela, Inc. | 12/12/1996SE |
| K954611 | Drager PT4000 Phototherapy SystemLBI · Traditional | Drager, Inc. | 12/01/1995SE |
| K940996 | Olympic Bili-LiteLBI · Traditional | Olympic Medical Corp. | 09/16/1994SE |
| K934946 | Biliblanket Plus Phototherapy SystemLBI · Traditional | Boc Health Care, Inc. | 07/05/1994SE |
| K931965 | Medix Phototherapy LampLBI · Traditional | Medix I.C.S.A. | 12/09/1993SE |
| K910571 | Biliblanket Light MeterLBI · Traditional | Ohmeda Medical | 07/28/1992SE |
| K912908 | Air-Shields Micro-Lite Phototherapy SystemLBI · Traditional | Air-Shields Vickers, Inc. | 12/13/1991SE |
| K903445 | Olympic Bili-Meter(Tm) with Type-F SensorLBI · Traditional | Olympic Medical Corp. | 10/29/1990SE |
| K902749 | Olympic Mini Bili-Lite, Model 77LBI · Traditional | Olympic Medical Corp. | 08/02/1990SE |
| K901987 | Olympic Bili-Lite-Pad(Tm)LBI · Traditional | Olympic Medical Corp. | 07/16/1990SE |
| K894129 | Biliblanket Phototherapy DeviceLBI · Traditional | Ohmeda Medical | 09/28/1989SE |
| K892940 | Precious Lite Model 4224LBI · Traditional | E & B Technologies, Inc. | 08/03/1989SE |
| K884133 | Preemicare Series 4000 Phototherapy LampLBI · Traditional | Preemicare Corp. | 03/08/1989SE |
| K883779 | Wallaby(Tm) BlanketLBI · Traditional | Fiberoptic Medical Products, Inc. | 11/14/1988SE |
| K882291 | Retrofit Baby Face Shield (RFS)LBI · Traditional | Physician Engineered Products, Inc. | 06/20/1988SE |
| K873700 | Institutional Bili Light (Ibl)LBI · Traditional | Physician Engineered Products, Inc. | 12/11/1987SE |
| K854122 | Precious Lite Model 4224LBI · Traditional | E & B Technologies, Inc. | 02/07/1986SE |
| K850599 | Home Bili Lights-Model 100LBI · Traditional | Physician Engineered Products, Inc. | 06/17/1985SE |
| K850181 | Aequitron MED-7100 Phototherapy LightLBI · Traditional | Aequitron Medical, Inc. | 04/05/1985SE |
| K834430 | Omni Infant Phototherapy UnitLBI · Traditional | Rocky Mountain Medical Corp. | 04/30/1984SE |
| K834335 | Ameda Phototherapy Lamp for NewbornLBI · Traditional | Egnell, Inc. | 04/20/1984SE |
| K840454 | Phototherapy Unit 7850 Neonatal PhotoLBI · Traditional | Air-Shields, Inc. | 03/23/1984SE |
| K832298 | Baby Light DosimeterLBI · Traditional | Rocky Mountain Medical Corp. | 10/19/1983SE |
| K830200 | Microelisa Minireader IILBI · Traditional | Dynatech Corp. | 02/16/1983SE |
| K813188 | Infant Phototherapy LightLBI · Traditional | Montrose Phototherapy Supply | 12/09/1981SE |
| K810953 | Model 533 Phototherapy UnitLBI · Traditional | Narco Air-Shields | 04/23/1981SE |
| K802702 | Neonatal Phototherapy UnitLBI · Traditional | Ohio Medical Products | 12/10/1980SE |
| K791114 | Bili-DosimeterLBI · Traditional | Olympic Medical Corp. | 09/04/1979SE |
| K771025 | Phototherapy/Procedure LampLBI · Traditional | Cavitron Corp. | 10/25/1977SE |
| K760872 | Phototherapy LightLBI · Traditional | Air-Shields, Inc. | 11/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0923-2020 Class II | Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533…There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below… | Lumitex Inc | 12/11/2019Terminated |
| Z-1924-2017 Class II | Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008.…The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will… | Natus Medical Incorporated | 04/03/2017Terminated |
| Z-1503-2017 Class II | Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-0770-2017 Class II | Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide…neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to… | Natus Medical Incorporated | 10/28/2016Terminated |
| Z-0769-2017 Class II | Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy…The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED… | Natus Medical Incorporated | 09/16/2016Terminated |
| Z-2001-2016 Class II | Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part…The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System… | Natus Medical Incorporated | 04/11/2016Terminated |
| Z-0149-2016 Class II | Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number:…The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared… | Natus Medical Incorporated | 08/05/2015Terminated |
| Z-1412-2015 Class II | Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224…neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers… | Natus Medical Incorporated | 03/16/2015Terminated |
| Z-0847-2015 Class II | Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2)…Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is… | Natus Medical Incorporated | 11/19/2014Terminated |
| Z-2486-2015 Class II | Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician…Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions | Physician Engineered Products, Inc. | 08/31/2013Terminated |
| Z-1950-2012 Class II | Drager PT 4000 Phototherapy SystemA routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp… | Draeger Medical Systems, Inc. | 07/02/2012Terminated |
| Z-0420-2010 | The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System".…The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress… | Natus Medical Incorporated | 10/01/2009Terminated |