Product Code: LBI
FDA class 2
21 CFR 880.5700
Unit, Neonatal Phototherapy
General Hospital
A neonatal phototherapy unit is a medical device used in hospital settings to treat hyperbilirubinemia (jaundice) in newborns by emitting specific wavelengths of light that break down bilirubin in the skin. It is classified as FDA Class 2, requiring 510(k) premarket clearance to demonstrate substantial equivalence. The product code is LBI, regulated under 21 CFR 880.5700, in the General Hospital specialty. Third-party review eligibility applies.
510(k)s
70
FEI Numbers
31
Registration Numbers
31
Unique Applicants
45
Years Active
49
Basic Information
- Product Code
- LBI
- Device Class
- FDA class 2
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 70 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243372 | BiliWrap | May 29, 2025 | Substantially Equivalent | Gerium Medical, Ltd. |
| K210289 | Infant Phototherapy Equipment | May 28, 2021 | Substantially Equivalent | Bistos Co., Ltd. |
| K200031 | Neonatal Phototherapy System | Oct 05, 2020 | Substantially Equivalent | Avalon Biomedical (Shenzhen) Limited |
| K190899 | bili-hut | Sep 05, 2019 | Substantially Equivalent | Little Sparrows Technologies, Inc. |
| K182178 | neoBLUE blanket LED Phototherapy System | Dec 13, 2018 | Substantially Equivalent | Natus Medical Incorporated |
| K172656 | BiliLux | May 01, 2018 | Substantially Equivalent | Draeger Medical Systems, Inc. |
| K170585 | Skylife | Oct 27, 2017 | Substantially Equivalent | NeoLight, LLC |
| K163526 | Bilicocoon Phototherapy System | Oct 06, 2017 | Substantially Equivalent | NEOMEDLIGHT |
| K160745 | neoBLUE compact LED Phototherapy System | Dec 12, 2016 | Substantially Equivalent | NATUS MEDICAL INCORPORATED |
| K160238 | Airborne Phototherapy Light | Jun 14, 2016 | Substantially Equivalent | INTERNATIONAL BIOMEDICAL |
| K160305 | neoBLUE® LED Phototherapy System | May 27, 2016 | Substantially Equivalent | Natus Medical Incorporated |
| K142332 | BT-400 | Mar 20, 2015 | Substantially Equivalent | Bio-Med USA |
| K131196 | INFANT PHOTOTHERAPY BILITRON SKY 5006 | Feb 20, 2014 | Substantially Equivalent | FANEM LDA |
| K120820 | GIRAFFE BLUE SPOT PT LITE | Jun 08, 2012 | Substantially Equivalent | LUMITEX, INC. |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | May 02, 2012 | Substantially Equivalent | WIPRO GE HEALTHCARE PRIVATE, LTD. |
| K111547 | BILI-THERAPY PAD TYPE | Apr 12, 2012 | Substantially Equivalent | ATOM MEDICAL CORPORATION |
| K113206 | NANOBLUTM 500 | Feb 17, 2012 | Substantially Equivalent | Draeger Medical Systems, Inc. |
| K110550 | BRIGHT EMBRACE MODEL SBL60 | Feb 03, 2012 | Substantially Equivalent | PHYSICIAN ENGINEERED PRODUCTS, INC. |
| K103735 | MEDILED MINI | Aug 15, 2011 | Substantially Equivalent | MEDIX I.C.S.A. |
| K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | May 13, 2011 | Substantially Equivalent | NATUS MEDICAL INCORPORATED |
| K103828 | BILI-THERAPY SPOT TYPE | Mar 29, 2011 | Substantially Equivalent | ATOM MEDICAL CORPORATION |
| K093618 | BILI-MIRROR MODEL BLM-1 | Apr 23, 2010 | Substantially Equivalent | PHYSICIAN ENGINEERED PRODUCTS, INC. |
| K090192 | BILI BLUE F20T12/BBY AND F40T12/BBY | Apr 24, 2009 | Substantially Equivalent | INTERLECTRIC CORP. |
| K083179 | MEDILED PHOTOTHERAPY LAMP | Feb 27, 2009 | Substantially Equivalent | MEDIX I.C.S.A. |
| K072097 | BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 | Oct 30, 2007 | Substantially Equivalent | MEDICAL SELECT, INC. |
| K071828 | LULLABY | Aug 06, 2007 | Substantially Equivalent | GE HEALTHCARE CLINICAL SYSTEMS |
| K070180 | WALLABY 4 | May 18, 2007 | Substantially Equivalent | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
| K053568 | BILISOFT PHOTOTHERAPY SYSTEM | Apr 17, 2006 | Substantially Equivalent | LUMITEX, INC. |
| K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | Oct 07, 2005 | Substantially Equivalent | NATUS MEDICAL, INC. |
| K040853 | PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 | Jun 21, 2004 | Substantially Equivalent | INTERNATIONAL HOSPITAL SUPPLY CO. |
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | Sep 19, 2002 | Substantially Equivalent | NATUS MEDICAL, INC. |
| K021531 | RPI REPLACEMENT PHOTOTHERAPY LIGHTS | May 31, 2002 | Substantially Equivalent | REPLACEMENT PARTS INDUSTRIES, INC. |
| K011549 | OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM | Jul 19, 2001 | Substantially Equivalent | OHMEDA MEDICAL |
| K010495 | CENTURA PHOTOTHERAPY SPOTLIGHT | Mar 09, 2001 | Substantially Equivalent | MEDICAL ILLUMINATION INTERNATIONAL, INC. |
| K002414 | PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE | Sep 25, 2000 | Substantially Equivalent | FISHER & PAYKEL HEALTHCARE, LTD. |
| K991627 | WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 | May 17, 1999 | Substantially Equivalent | RESPIRONICS, INC. |
| K984589 | PHOTOTHERAPY LAMP | Apr 20, 1999 | Substantially Equivalent | MEDELA, INC. |
| K974830 | ULTRA BILI LIGHT | May 20, 1998 | Substantially Equivalent | PHYSICIAN ENGINEERED PRODUCTS, INC. |
| K971601 | OLYMPIC BILI-BASSINET | Sep 24, 1997 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | Sep 24, 1997 | Substantially Equivalent | AIR-SHIELDS, INC. |
| K962612 | BILIBED PHOTOTHERAPY LAMP | Dec 12, 1996 | Substantially Equivalent | MEDELA, INC. |
| K954611 | DRAGER PT4000 PHOTOTHERAPY SYSTEM | Dec 01, 1995 | Substantially Equivalent | DRAGER, INC. |
| K940996 | OLYMPIC BILI-LITE | Sep 16, 1994 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K934946 | BILIBLANKET PLUS PHOTOTHERAPY SYSTEM | Jul 05, 1994 | Substantially Equivalent | BOC HEALTH CARE, INC. |
| K931965 | MEDIX PHOTOTHERAPY LAMP | Dec 09, 1993 | Substantially Equivalent | MEDIX I.C.S.A. |
| K910571 | BILIBLANKET LIGHT METER | Jul 28, 1992 | Substantially Equivalent | OHMEDA MEDICAL |
| K912908 | AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM | Dec 13, 1991 | Substantially Equivalent | AIR-SHIELDS VICKERS, INC. |
| K903445 | OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR | Oct 29, 1990 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K902749 | OLYMPIC MINI BILI-LITE, MODEL 77 | Aug 02, 1990 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K901987 | OLYMPIC BILI-LITE-PAD(TM) | Jul 16, 1990 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K894129 | BILIBLANKET PHOTOTHERAPY DEVICE | Sep 28, 1989 | Substantially Equivalent | OHMEDA MEDICAL |
| K892940 | PRECIOUS LITE MODEL 4224 | Aug 03, 1989 | Substantially Equivalent | E & B TECHNOLOGIES, INC. |
| K884133 | PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP | Mar 08, 1989 | Substantially Equivalent | PREEMICARE CORP. |
| K883779 | WALLABY(TM) BLANKET | Nov 14, 1988 | Substantially Equivalent | FIBEROPTIC MEDICAL PRODUCTS, INC. |
| K882291 | RETROFIT BABY FACE SHIELD (RFS) | Jun 20, 1988 | Substantially Equivalent | PHYSICIAN ENGINEERED PRODUCTS, INC. |
| K873700 | INSTITUTIONAL BILI LIGHT (IBL) | Dec 11, 1987 | Substantially Equivalent | PHYSICIAN ENGINEERED PRODUCTS, INC. |
| K854122 | PRECIOUS LITE MODEL 4224 | Feb 07, 1986 | Substantially Equivalent | E & B TECHNOLOGIES, INC. |
| K850599 | HOME BILI LIGHTS-MODEL 100 | Jun 17, 1985 | Substantially Equivalent | PHYSICIAN ENGINEERED PRODUCTS, INC. |
| K850181 | AEQUITRON MED-7100 PHOTOTHERAPY LIGHT | Apr 05, 1985 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K834430 | OMNI INFANT PHOTOTHERAPY UNIT | Apr 30, 1984 | Substantially Equivalent | ROCKY MOUNTAIN MEDICAL CORP. |
| K834335 | AMEDA PHOTOTHERAPY LAMP FOR NEWBORN | Apr 20, 1984 | Substantially Equivalent | EGNELL, INC. |
| K840454 | PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO | Mar 23, 1984 | Substantially Equivalent | AIR-SHIELDS, INC. |
| K832298 | BABY LIGHT DOSIMETER | Oct 19, 1983 | Substantially Equivalent | ROCKY MOUNTAIN MEDICAL CORP. |
| K830200 | MICROELISA MINIREADER II | Feb 16, 1983 | Substantially Equivalent | DYNATECH CORP. |
| K813188 | INFANT PHOTOTHERAPY LIGHT | Dec 09, 1981 | Substantially Equivalent | MONTROSE PHOTOTHERAPY SUPPLY |
| K810953 | MODEL 533 PHOTOTHERAPY UNIT | Apr 23, 1981 | Substantially Equivalent | NARCO AIR-SHIELDS |
| K802702 | NEONATAL PHOTOTHERAPY UNIT | Dec 10, 1980 | Substantially Equivalent | OHIO MEDICAL PRODUCTS |
| K791114 | BILI-DOSIMETER | Sep 04, 1979 | Substantially Equivalent | OLYMPIC MEDICAL CORP. |
| K771025 | PHOTOTHERAPY/PROCEDURE LAMP | Oct 25, 1977 | Substantially Equivalent | CAVITRON CORP. |
| K760872 | PHOTOTHERAPY LIGHT | Nov 02, 1976 | Substantially Equivalent | AIR-SHIELDS, INC. |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.