Unit, Neonatal Phototherapy
FDA product code LBI · 69 cleared devices
Class 2
General Hospital
- Regulation
- 21 CFR 880.5700
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-02 – 2026-01-15
LBI
2026-01-15
LBI
2025-05-29
BiliWrap
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LBI
2021-05-28
Infant Phototherapy Equipment
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LBI
2020-10-05
Neonatal Phototherapy System
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LBI
2019-09-05
bili-hut
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LBI
2018-12-13
neoBLUE blanket LED Phototherapy System
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LBI
2018-05-01
BiliLux
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LBI
2017-10-27
Skylife
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LBI
2017-10-06
Bilicocoon™ Phototherapy System
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LBI
2016-12-12
neoBLUE compact LED Phototherapy System
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LBI
2016-06-14
Airborne Phototherapy Light
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LBI
2016-05-27
neoBLUE® LED Phototherapy System
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LBI
2012-06-08
GIRAFFE BLUE SPOT PT LITE
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LBI
2012-05-02
LULLABY LED PHOTTHERAPY SYSTEM
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LBI
2012-04-12
BILI-THERAPY PAD TYPE
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LBI
2012-02-17
NANOBLUTM 500
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LBI
2012-02-03
BRIGHT EMBRACE MODEL SBL60
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LBI
2011-08-15
MEDILED MINI
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LBI
2011-05-13
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
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LBI
2011-03-29
BILI-THERAPY SPOT TYPE
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LBI
2010-04-23
BILI-MIRROR MODEL BLM-1
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LBI
2009-04-24
BILI BLUE F20T12/BBY AND F40T12/BBY
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LBI
2009-02-27
MEDILED PHOTOTHERAPY LAMP
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LBI
2007-10-30
BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
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LBI
2007-08-06
LULLABY
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LBI
2007-05-18
WALLABY 4
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LBI
2006-04-17
BILISOFT PHOTOTHERAPY SYSTEM
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LBI
2005-10-07
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
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LBI
2004-06-21
PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
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LBI
2002-09-19
NATUS BLUE LIGHT PHOTOTHERAPY UNIT
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LBI
2002-05-31
RPI REPLACEMENT PHOTOTHERAPY LIGHTS
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LBI
2001-07-19
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
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LBI
2001-03-09
CENTURA PHOTOTHERAPY SPOTLIGHT
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LBI
2000-09-25
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
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LBI
1999-05-17
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
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LBI
1999-04-20
PHOTOTHERAPY LAMP
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LBI
1998-05-20
ULTRA BILI LIGHT
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LBI
1997-09-24
OLYMPIC BILI-BASSINET
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LBI
1997-09-24
DUO-LITE PHOTOTHERAPY SYSTEM
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LBI
1996-12-12
BILIBED PHOTOTHERAPY LAMP
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LBI
1995-12-01
DRAGER PT4000 PHOTOTHERAPY SYSTEM
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LBI
1994-09-16
OLYMPIC BILI-LITE
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LBI
1994-07-05
BILIBLANKET PLUS PHOTOTHERAPY SYSTEM
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LBI
1993-12-09
MEDIX PHOTOTHERAPY LAMP
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LBI
1992-07-28
BILIBLANKET LIGHT METER
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LBI
1991-12-13
AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM
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LBI
1990-10-29
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
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LBI
1990-08-02
OLYMPIC MINI BILI-LITE, MODEL 77
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LBI
1990-07-16
OLYMPIC BILI-LITE-PAD(TM)
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LBI
1989-09-28
BILIBLANKET PHOTOTHERAPY DEVICE
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LBI
1989-08-03
PRECIOUS LITE MODEL 4224
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LBI
1989-03-08
PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
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LBI
1988-11-14
WALLABY(TM) BLANKET
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LBI
1988-06-20
RETROFIT BABY FACE SHIELD (RFS)
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LBI
1987-12-11
INSTITUTIONAL BILI LIGHT (IBL)
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LBI
1986-02-07
PRECIOUS LITE MODEL 4224
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LBI
1985-06-17
HOME BILI LIGHTS-MODEL 100
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LBI
1985-04-05
AEQUITRON MED-7100 PHOTOTHERAPY LIGHT
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LBI
1984-04-30
OMNI INFANT PHOTOTHERAPY UNIT
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LBI
1984-04-20
AMEDA PHOTOTHERAPY LAMP FOR NEWBORN
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LBI
1984-03-23
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
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LBI
1983-10-19
BABY LIGHT DOSIMETER
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LBI
1983-02-16
MICROELISA MINIREADER II
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LBI
1981-12-09
INFANT PHOTOTHERAPY LIGHT
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LBI
1981-04-23
MODEL 533 PHOTOTHERAPY UNIT
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LBI
1980-12-10
NEONATAL PHOTOTHERAPY UNIT
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LBI
1979-09-04
BILI-DOSIMETER
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LBI
1977-10-25
PHOTOTHERAPY/PROCEDURE LAMP
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LBI
1976-11-02
PHOTOTHERAPY LIGHT
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