Atlas FDA

LBI

71 FDA 510(k) clearances · Product code

116 daysmedian time to decision
262 days90th percentile
71clearances measured

FDA profile

Official device name
Unit, Neonatal Phototherapy
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5700
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 9 · 2011: 5 · 2013: 6 · 2016: 22 · 2017: 577 · 2018: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (K251308)Thera B Medical Products2026-01-15
BiliWrap (K243372)Gerium Medical, Ltd.2025-05-29
Infant Phototherapy Equipment (K210289)Bistos Co., Ltd.2021-05-28
Neonatal Phototherapy System (K200031)Avalon Biomedical (Shenzhen) Limited2020-10-05
bili-hut (K190899)Little Sparrows Technologies, Inc.2019-09-05
neoBLUE blanket LED Phototherapy System (K182178)Natus Medical Incorporated2018-12-13
BiliLux (K172656)Draeger Medical Systems, Inc.2018-05-01
Skylife (K170585)Neolight, LLC2017-10-27
Bilicocoon™ Phototherapy System (K163526)Neomedlight2017-10-06
neoBLUE compact LED Phototherapy System (K160745)Natus Medical Incorporated2016-12-12
Airborne Phototherapy Light (K160238)International Biomedical2016-06-14
neoBLUE® LED Phototherapy System (K160305)Natus Medical Incorporated2016-05-27
BT-400 (K142332)Bio-Med USA2015-03-20
INFANT PHOTOTHERAPY BILITRON SKY 5006 (K131196)Fanem Lda2014-02-20
GIRAFFE BLUE SPOT PT LITE (K120820)Lumitex, Inc.2012-06-08
LULLABY LED PHOTTHERAPY SYSTEM (K120168)Wipro GE Healthcare Private, Ltd.2012-05-02
BILI-THERAPY PAD TYPE (K111547)Atom Medical Corporation2012-04-12
NANOBLUTM 500 (K113206)Draeger Medical Systems, Inc.2012-02-17
BRIGHT EMBRACE MODEL SBL60 (K110550)Physician Engineered Products, Inc.2012-02-03
MEDILED MINI (K103735)Medix I.C.S.A.2011-08-15
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM (K103589)Natus Medical Incorporated2011-05-13
BILI-THERAPY SPOT TYPE (K103828)Atom Medical Corporation2011-03-29
BILI-MIRROR MODEL BLM-1 (K093618)Physician Engineered Products, Inc.2010-04-23
BILI BLUE F20T12/BBY AND F40T12/BBY (K090192)Interlectric Corp.2009-04-24
MEDILED PHOTOTHERAPY LAMP (K083179)Medix I.C.S.A.2009-02-27
BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 (K072097)Medical Select, Inc.2007-10-30
LULLABY (K071828)Ge Healthcare Clinical Systems2007-08-06
WALLABY 4 (K070180)Respironics Inc., Sleep & Home Respiratory Group2007-05-18
BILISOFT PHOTOTHERAPY SYSTEM (K053568)Lumitex, Inc.2006-04-17
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (K051869)Natus Medical, Inc.2005-10-07
PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 (K040853)International Hospital Supply Co.2004-06-21
NATUS BLUE LIGHT PHOTOTHERAPY UNIT (K022196)Natus Medical, Inc.2002-09-19
RPI REPLACEMENT PHOTOTHERAPY LIGHTS (K021531)Replacement Parts Industries, Inc.2002-05-31
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM (K011549)Ohmeda Medical2001-07-19
CENTURA PHOTOTHERAPY SPOTLIGHT (K010495)Medical Illumination International, Inc.2001-03-09
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE (K002414)Fisher & Paykel Healthcare, Ltd.2000-09-25
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 (K991627)Respironics, Inc.1999-05-17
PHOTOTHERAPY LAMP (K984589)Medela, Inc.1999-04-20
ULTRA BILI LIGHT (K974830)Physician Engineered Products, Inc.1998-05-20
DUO-LITE PHOTOTHERAPY SYSTEM (K971256)Air-Shields, Inc.1997-09-24
OLYMPIC BILI-BASSINET (K971601)Olympic Medical Corp.1997-09-24
BILIBED PHOTOTHERAPY LAMP (K962612)Medela, Inc.1996-12-12
DRAGER PT4000 PHOTOTHERAPY SYSTEM (K954611)Drager, Inc.1995-12-01
OLYMPIC BILI-LITE (K940996)Olympic Medical Corp.1994-09-16
BILIBLANKET PLUS PHOTOTHERAPY SYSTEM (K934946)Boc Health Care, Inc.1994-07-05
MEDIX PHOTOTHERAPY LAMP (K931965)Medix I.C.S.A.1993-12-09
BILIBLANKET LIGHT METER (K910571)Ohmeda Medical1992-07-28
AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM (K912908)Air-Shields Vickers, Inc.1991-12-13
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR (K903445)Olympic Medical Corp.1990-10-29
OLYMPIC MINI BILI-LITE, MODEL 77 (K902749)Olympic Medical Corp.1990-08-02
OLYMPIC BILI-LITE-PAD(TM) (K901987)Olympic Medical Corp.1990-07-16
BILIBLANKET PHOTOTHERAPY DEVICE (K894129)Ohmeda Medical1989-09-28
PRECIOUS LITE MODEL 4224 (K892940)E & B Technologies, Inc.1989-08-03
PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP (K884133)Preemicare Corp.1989-03-08
WALLABY(TM) BLANKET (K883779)Fiberoptic Medical Products, Inc.1988-11-14
RETROFIT BABY FACE SHIELD (RFS) (K882291)Physician Engineered Products, Inc.1988-06-20
INSTITUTIONAL BILI LIGHT (IBL) (K873700)Physician Engineered Products, Inc.1987-12-11
PRECIOUS LITE MODEL 4224 (K854122)E & B Technologies, Inc.1986-02-07
HOME BILI LIGHTS-MODEL 100 (K850599)Physician Engineered Products, Inc.1985-06-17
AEQUITRON MED-7100 PHOTOTHERAPY LIGHT (K850181)Aequitron Medical, Inc.1985-04-05
OMNI INFANT PHOTOTHERAPY UNIT (K834430)Rocky Mountain Medical Corp.1984-04-30
AMEDA PHOTOTHERAPY LAMP FOR NEWBORN (K834335)Egnell, Inc.1984-04-20
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO (K840454)Air-Shields, Inc.1984-03-23
BABY LIGHT DOSIMETER (K832298)Rocky Mountain Medical Corp.1983-10-19
MICROELISA MINIREADER II (K830200)Dynatech Corp.1983-02-16
INFANT PHOTOTHERAPY LIGHT (K813188)Montrose Phototherapy Supply1981-12-09
MODEL 533 PHOTOTHERAPY UNIT (K810953)Narco Air-Shields1981-04-23
NEONATAL PHOTOTHERAPY UNIT (K802702)Ohio Medical Products1980-12-10
BILI-DOSIMETER (K791114)Olympic Medical Corp.1979-09-04
PHOTOTHERAPY/PROCEDURE LAMP (K771025)Cavitron Corp.1977-10-25
PHOTOTHERAPY LIGHT (K760872)Air-Shields, Inc.1976-11-02

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