FDA.reportPublic FDA data

Light Module

Primary DI
30852788008058
Brand
Light Module
Company
NEOLIGHT LLC
Model
NL-SK-3
Device description
Light Modules (2) installed in system
Published
2018-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LBIUnit, Neonatal Phototherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBIUnit, Neonatal PhototherapyGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170585000SkylifeNeolight, LLC2017-10-27LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30852788008058PackageGS12In Commercial Distribution
10852788008054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085278800805830852788008058
1085278800805410852788008054

GMDN Terms#

Term, Definition table
TermDefinition
Blanket/pad infant phototherapy unitA device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a fibreoptic-light source that connects through a flexible fibreoptic cable to a transparent blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. This device can be suitable for home-use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
074301687
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852788008101NeoLight Bassinet Basket Loaner300064NEO-BASK-LNR2025-04-09
00852788008019NeolightPCI 40-10032025-01-26
00852788008026NeolightPCI 40-10042025-01-26
00852788008040NeolightPCI 40-10172025-01-26
00852788008057NeolightPCI 40-10302025-01-26
00852788008064NeolightPCI 30-10002025-01-26
00852788008071NeolightPCI 40-10052025-01-26
10852788008085NeolightPCI 40-10022025-01-26
20852788008020NeolightPCI 40-1100FA2025-01-26
20852788008037NeolightPCI 40-1100 2025-01-26
20852788008044NeolightPCI 40-21002025-01-26
20852788008051NeolightPCI 40-2100FA2025-01-26
00852788008217NeoLight Bassinet Basket300063NEO-BASK2024-12-31
10852788008054Light ModuleNL-SK-32018-11-09
10852788008047CloudCover PlusNL-SK-8SNL-SK-8S2020-11-11
10852788008177CloudCoverNL-SK-5SNL-SK-5S2020-11-11
10852788008009Skylife LightbedNL-SK-22018-11-09
10852788008016Skylife ControllerNL-SK-12018-11-09
10852788008023GelMatNL-SK-2-2122018-11-09
10852788008078Skylife SystemNL-SK2018-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760012570102BiliCocoon™ Light BoxNEOMEDLIGHTLBI2026-04-27
03760012570126BiliCocoon™ Bag SystemNEOMEDLIGHTLBI2026-04-27
03760012570133BiliCocoon™ Bag DisposableNEOMEDLIGHTLBI2026-04-27
03760012570171BiliCocoon™ Nest SystemNEOMEDLIGHTLBI2026-04-27
03760012570188BiliCocoon™ Nest PadNEOMEDLIGHTLBI2026-04-27
03760012570195BiliCocoon™ Nest DisposableNEOMEDLIGHTLBI2026-04-27
03760012570218BiliCocoon™ Fixation SystemNEOMEDLIGHTLBI2026-04-27
03760012570225BiliCocoon™ Service KitNEOMEDLIGHTLBI2026-04-27
03760012570249BiliCocoon™ Bag PadNEOMEDLIGHTLBI2026-04-27
05713315011252NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011269NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011276NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011283NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011313NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011351NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011405NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011849NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011856NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011863NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
00810101280603bili-hut™ disposable nest mattress coverLITTLE SPARROWS TECHNOLOGIES LLCLBI2025-11-25
05713315011214NeoBLUE NovaNatus Medical Denmark ApSLBI2025-05-27
05713315011221NeoblueNatus Medical Denmark ApSLBI2025-05-27
05713315011238NeoBLUE NovaNatus Medical Denmark ApSLBI2025-05-27
B510PT2000ADVANCED LED PHOTOTHERAPY LAMPADVANCED INSTRUMENTATIONS, INC.LBI2025-02-07
B510PT5000ADVANCED LED PHOTOTHERAPY LAMPADVANCED INSTRUMENTATIONS, INC.LBI2025-02-07
00810101280504bili-hut™ fully disposable nest & mattress (5-Pack)LITTLE SPARROWS TECHNOLOGIES LLCLBI2024-03-26
00810101280542bili-hut™ fully disposable convenience kit (5-Pack) LITTLE SPARROWS TECHNOLOGIES LLCLBI2024-03-26
00810101280023bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10
00810101280047bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10
00810101280054bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10