FDA Product Code
FDA Product Code LBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5700
510(k) Clearances — 71 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | 2026-01-15 | Traditional | PDF ↗ |
| K243372 | BiliWrap | Gerium Medical, Ltd. | 2025-05-29 | Traditional | PDF ↗ |
| K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021-05-28 | Traditional | PDF ↗ |
| K200031 | Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited | 2020-10-05 | Traditional | PDF ↗ |
| K190899 | bili-hut | Little Sparrows Technologies, Inc. | 2019-09-05 | Traditional | PDF ↗ |
| K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | 2018-12-13 | Traditional | PDF ↗ |
| K172656 | BiliLux | Draeger Medical Systems, Inc. | 2018-05-01 | Traditional | PDF ↗ |
| K170585 | Skylife | Neolight, LLC | 2017-10-27 | Traditional | PDF ↗ |
| K163526 | Bilicocoon Phototherapy System | Neomedlight | 2017-10-06 | Traditional | PDF ↗ |
| K160745 | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | 2016-12-12 | Traditional | PDF ↗ |
| K160238 | Airborne Phototherapy Light | International Biomedical | 2016-06-14 | Abbreviated | PDF ↗ |
| K160305 | neoBLUE® LED Phototherapy System | Natus Medical Incorporated | 2016-05-27 | Traditional | PDF ↗ |
| K142332 | BT-400 | Bio-Med USA | 2015-03-20 | Traditional | PDF ↗ |
| K131196 | INFANT PHOTOTHERAPY BILITRON SKY 5006 | Fanem Lda | 2014-02-20 | Traditional | PDF ↗ |
| K120820 | GIRAFFE BLUE SPOT PT LITE | Lumitex, Inc. | 2012-06-08 | Traditional | PDF ↗ |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | Wipro GE Healthcare Private, Ltd. | 2012-05-02 | Traditional | PDF ↗ |
| K111547 | BILI-THERAPY PAD TYPE | Atom Medical Corporation | 2012-04-12 | Traditional | PDF ↗ |
| K113206 | NANOBLUTM 500 | Draeger Medical Systems, Inc. | 2012-02-17 | Traditional | PDF ↗ |
| K110550 | BRIGHT EMBRACE MODEL SBL60 | Physician Engineered Products, Inc. | 2012-02-03 | Traditional | PDF ↗ |
| K103735 | MEDILED MINI | Medix I.C.S.A. | 2011-08-15 | Traditional | PDF ↗ |
| K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | Natus Medical Incorporated | 2011-05-13 | Traditional | PDF ↗ |
| K103828 | BILI-THERAPY SPOT TYPE | Atom Medical Corporation | 2011-03-29 | Traditional | PDF ↗ |
| K093618 | BILI-MIRROR MODEL BLM-1 | Physician Engineered Products, Inc. | 2010-04-23 | Traditional | PDF ↗ |
| K090192 | BILI BLUE F20T12/BBY AND F40T12/BBY | Interlectric Corp. | 2009-04-24 | Traditional | PDF ↗ |
| K083179 | MEDILED PHOTOTHERAPY LAMP | Medix I.C.S.A. | 2009-02-27 | Traditional | PDF ↗ |
| K072097 | BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 | Medical Select, Inc. | 2007-10-30 | Traditional | PDF ↗ |
| K071828 | LULLABY | Ge Healthcare Clinical Systems | 2007-08-06 | Traditional | PDF ↗ |
| K070180 | WALLABY 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007-05-18 | Traditional | PDF ↗ |
| K053568 | BILISOFT PHOTOTHERAPY SYSTEM | Lumitex, Inc. | 2006-04-17 | Traditional | PDF ↗ |
| K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | Natus Medical, Inc. | 2005-10-07 | Traditional | PDF ↗ |
| K040853 | PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 | International Hospital Supply Co. | 2004-06-21 | Traditional | PDF ↗ |
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | Natus Medical, Inc. | 2002-09-19 | Traditional | PDF ↗ |
| K021531 | RPI REPLACEMENT PHOTOTHERAPY LIGHTS | Replacement Parts Industries, Inc. | 2002-05-31 | Traditional | PDF ↗ |
| K011549 | OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM | Ohmeda Medical | 2001-07-19 | Traditional | PDF ↗ |
| K010495 | CENTURA PHOTOTHERAPY SPOTLIGHT | Medical Illumination International, Inc. | 2001-03-09 | Traditional | PDF ↗ |
| K002414 | PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE | Fisher & Paykel Healthcare, Ltd. | 2000-09-25 | Traditional | PDF ↗ |
| K991627 | WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 | Respironics, Inc. | 1999-05-17 | Special | PDF ↗ |
| K984589 | PHOTOTHERAPY LAMP | Medela, Inc. | 1999-04-20 | Traditional | PDF ↗ |
| K974830 | ULTRA BILI LIGHT | Physician Engineered Products, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | Air-Shields, Inc. | 1997-09-24 | Traditional | PDF ↗ |
| K971601 | OLYMPIC BILI-BASSINET | Olympic Medical Corp. | 1997-09-24 | Traditional | PDF ↗ |
| K962612 | BILIBED PHOTOTHERAPY LAMP | Medela, Inc. | 1996-12-12 | Traditional | PDF ↗ |
| K954611 | DRAGER PT4000 PHOTOTHERAPY SYSTEM | Drager, Inc. | 1995-12-01 | Traditional | PDF ↗ |
| K940996 | OLYMPIC BILI-LITE | Olympic Medical Corp. | 1994-09-16 | Traditional | PDF ↗ |
| K934946 | BILIBLANKET PLUS PHOTOTHERAPY SYSTEM | Boc Health Care, Inc. | 1994-07-05 | Traditional | PDF ↗ |
| K931965 | MEDIX PHOTOTHERAPY LAMP | Medix I.C.S.A. | 1993-12-09 | Traditional | PDF ↗ |
| K910571 | BILIBLANKET LIGHT METER | Ohmeda Medical | 1992-07-28 | Traditional | PDF ↗ |
| K912908 | AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM | Air-Shields Vickers, Inc. | 1991-12-13 | Traditional | PDF ↗ |
| K903445 | OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR | Olympic Medical Corp. | 1990-10-29 | Traditional | PDF ↗ |
| K902749 | OLYMPIC MINI BILI-LITE, MODEL 77 | Olympic Medical Corp. | 1990-08-02 | Traditional | PDF ↗ |
| K901987 | OLYMPIC BILI-LITE-PAD(TM) | Olympic Medical Corp. | 1990-07-16 | Traditional | PDF ↗ |
| K894129 | BILIBLANKET PHOTOTHERAPY DEVICE | Ohmeda Medical | 1989-09-28 | Traditional | PDF ↗ |
| K892940 | PRECIOUS LITE MODEL 4224 | E & B Technologies, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K884133 | PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP | Preemicare Corp. | 1989-03-08 | Traditional | PDF ↗ |
| K883779 | WALLABY(TM) BLANKET | Fiberoptic Medical Products, Inc. | 1988-11-14 | Traditional | PDF ↗ |
| K882291 | RETROFIT BABY FACE SHIELD (RFS) | Physician Engineered Products, Inc. | 1988-06-20 | Traditional | PDF ↗ |
| K873700 | INSTITUTIONAL BILI LIGHT (IBL) | Physician Engineered Products, Inc. | 1987-12-11 | Traditional | PDF ↗ |
| K854122 | PRECIOUS LITE MODEL 4224 | E & B Technologies, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K850599 | HOME BILI LIGHTS-MODEL 100 | Physician Engineered Products, Inc. | 1985-06-17 | Traditional | PDF ↗ |
| K850181 | AEQUITRON MED-7100 PHOTOTHERAPY LIGHT | Aequitron Medical, Inc. | 1985-04-05 | Traditional | PDF ↗ |
| K834430 | OMNI INFANT PHOTOTHERAPY UNIT | Rocky Mountain Medical Corp. | 1984-04-30 | Traditional | PDF ↗ |
| K834335 | AMEDA PHOTOTHERAPY LAMP FOR NEWBORN | Egnell, Inc. | 1984-04-20 | Traditional | PDF ↗ |
| K840454 | PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO | Air-Shields, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K832298 | BABY LIGHT DOSIMETER | Rocky Mountain Medical Corp. | 1983-10-19 | Traditional | PDF ↗ |
| K830200 | MICROELISA MINIREADER II | Dynatech Corp. | 1983-02-16 | Traditional | PDF ↗ |
| K813188 | INFANT PHOTOTHERAPY LIGHT | Montrose Phototherapy Supply | 1981-12-09 | Traditional | PDF ↗ |
| K810953 | MODEL 533 PHOTOTHERAPY UNIT | Narco Air-Shields | 1981-04-23 | Traditional | PDF ↗ |
| K802702 | NEONATAL PHOTOTHERAPY UNIT | Ohio Medical Products | 1980-12-10 | Traditional | PDF ↗ |
| K791114 | BILI-DOSIMETER | Olympic Medical Corp. | 1979-09-04 | Traditional | PDF ↗ |
| K771025 | PHOTOTHERAPY/PROCEDURE LAMP | Cavitron Corp. | 1977-10-25 | Traditional | PDF ↗ |
| K760872 | PHOTOTHERAPY LIGHT | Air-Shields, Inc. | 1976-11-02 | Traditional | PDF ↗ |
Product code LBI · Class II · General Hospital. Data: openFDA.