FDA 510(k) Applications for Medical Device Product Code "LBI"
(Unit, Neonatal Phototherapy)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K971256 | AIR-SHIELDS, INC. | DUO-LITE PHOTOTHERAPY SYSTEM | 09/24/1997 |
| K111547 | ATOM MEDICAL CORPORATION | BILI-THERAPY PAD TYPE | 04/12/2012 |
| K103828 | ATOM MEDICAL CORPORATION | BILI-THERAPY SPOT TYPE | 03/29/2011 |
| K200031 | Avalon Biomedical (Shenzhen) Limited | Neonatal Phototherapy System | 10/05/2020 |
| K142332 | Bio-Med USA | BT-400 | 03/20/2015 |
| K210289 | Bistos Co., Ltd. | Infant Phototherapy Equipment | 05/28/2021 |
| K172656 | Draeger Medical Systems, Inc. | BiliLux | 05/01/2018 |
| K113206 | Draeger Medical Systems, Inc. | NANOBLUTM 500 | 02/17/2012 |
| K131196 | FANEM LDA | INFANT PHOTOTHERAPY BILITRON SKY 5006 | 02/20/2014 |
| K002414 | FISHER & PAYKEL HEALTHCARE, LTD. | PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE | 09/25/2000 |
| K071828 | GE HEALTHCARE CLINICAL SYSTEMS | LULLABY | 08/06/2007 |
| K090192 | INTERLECTRIC CORP. | BILI BLUE F20T12/BBY AND F40T12/BBY | 04/24/2009 |
| K160238 | INTERNATIONAL BIOMEDICAL | Airborne Phototherapy Light | 06/14/2016 |
| K040853 | INTERNATIONAL HOSPITAL SUPPLY CO. | PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 | 06/21/2004 |
| K190899 | Little Sparrows Technologies, Inc. | bili-hut | 09/05/2019 |
| K053568 | LUMITEX, INC. | BILISOFT PHOTOTHERAPY SYSTEM | 04/17/2006 |
| K120820 | LUMITEX, INC. | GIRAFFE BLUE SPOT PT LITE | 06/08/2012 |
| K962612 | MEDELA, INC. | BILIBED PHOTOTHERAPY LAMP | 12/12/1996 |
| K984589 | MEDELA, INC. | PHOTOTHERAPY LAMP | 04/20/1999 |
| K010495 | MEDICAL ILLUMINATION INTERNATIONAL, INC. | CENTURA PHOTOTHERAPY SPOTLIGHT | 03/09/2001 |
| K072097 | MEDICAL SELECT, INC. | BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 | 10/30/2007 |
| K103735 | MEDIX I.C.S.A. | MEDILED MINI | 08/15/2011 |
| K083179 | MEDIX I.C.S.A. | MEDILED PHOTOTHERAPY LAMP | 02/27/2009 |
| K103589 | NATUS MEDICAL INCORPORATED | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | 05/13/2011 |
| K182178 | Natus Medical Incorporated | neoBLUE blanket LED Phototherapy System | 12/13/2018 |
| K160745 | NATUS MEDICAL INCORPORATED | neoBLUE compact LED Phototherapy System | 12/12/2016 |
| K160305 | Natus Medical Incorporated | neoBLUE« LED Phototherapy System | 05/27/2016 |
| K022196 | NATUS MEDICAL, INC. | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | 09/19/2002 |
| K051869 | NATUS MEDICAL, INC. | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | 10/07/2005 |
| K170585 | NeoLight, LLC | Skylife | 10/27/2017 |
| K163526 | NEOMEDLIGHT | BilicocoonÖ Phototherapy System | 10/06/2017 |
| K011549 | OHMEDA MEDICAL | OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM | 07/19/2001 |
| K971601 | OLYMPIC MEDICAL CORP. | OLYMPIC BILI-BASSINET | 09/24/1997 |
| K093618 | PHYSICIAN ENGINEERED PRODUCTS, INC. | BILI-MIRROR MODEL BLM-1 | 04/23/2010 |
| K110550 | PHYSICIAN ENGINEERED PRODUCTS, INC. | BRIGHT EMBRACE MODEL SBL60 | 02/03/2012 |
| K974830 | PHYSICIAN ENGINEERED PRODUCTS, INC. | ULTRA BILI LIGHT | 05/20/1998 |
| K021531 | REPLACEMENT PARTS INDUSTRIES, INC. | RPI REPLACEMENT PHOTOTHERAPY LIGHTS | 05/31/2002 |
| K070180 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | WALLABY 4 | 05/18/2007 |
| K991627 | RESPIRONICS, INC. | WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 | 05/17/1999 |
| K120168 | WIPRO GE HEALTHCARE PRIVATE, LTD. | LULLABY LED PHOTTHERAPY SYSTEM | 05/02/2012 |
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