Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- K243372BiliWrap2Cleared 510(K)
- K210289Infant Phototherapy Equipment2Cleared 510(K)
- K200031Neonatal Phototherapy System2Cleared 510(K)
- K190899bili-hut2Cleared 510(K)
- K182178neoBLUE blanket LED Phototherapy System2Cleared 510(K)
- K172656BiliLux2Cleared 510(K)
- K170585Skylife2Cleared 510(K)
- K163526Bilicocoon™ Phototherapy System2Cleared 510(K)
- K160745neoBLUE compact LED Phototherapy System2Cleared 510(K)
- K160238Airborne Phototherapy Light2Cleared 510(K)
- K160305neoBLUE® LED Phototherapy System2Cleared 510(K)
- K142332BT-4002Cleared 510(K)
- K131196INFANT PHOTOTHERAPY BILITRON SKY 50062Cleared 510(K)
- K120820GIRAFFE BLUE SPOT PT LITE2Cleared 510(K)
- K120168LULLABY LED PHOTTHERAPY SYSTEM2Cleared 510(K)
- K111547BILI-THERAPY PAD TYPE2Cleared 510(K)
- K113206NANOBLUTM 5002Cleared 510(K)
- K110550BRIGHT EMBRACE MODEL SBL602Cleared 510(K)
- K103735MEDILED MINI2Cleared 510(K)
- K103589NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K103828BILI-THERAPY SPOT TYPE2Cleared 510(K)
- K093618BILI-MIRROR MODEL BLM-12Cleared 510(K)
- K090192BILI BLUE F20T12/BBY AND F40T12/BBY2Cleared 510(K)
- K083179MEDILED PHOTOTHERAPY LAMP2Cleared 510(K)
- K072097BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 12Cleared 510(K)
- K071828LULLABY2Cleared 510(K)
- K070180WALLABY 42Cleared 510(K)
- K053568BILISOFT PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K051869NEOBLUE COZY LED PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K040853PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 1012Cleared 510(K)
- K022196NATUS BLUE LIGHT PHOTOTHERAPY UNIT2Cleared 510(K)
- K021531RPI REPLACEMENT PHOTOTHERAPY LIGHTS2Cleared 510(K)
- K011549OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K010495CENTURA PHOTOTHERAPY SPOTLIGHT2Cleared 510(K)
- K002414PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE2Cleared 510(K)
- K991627WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 36002Cleared 510(K)
- K984589PHOTOTHERAPY LAMP2Cleared 510(K)
- K974830ULTRA BILI LIGHT2Cleared 510(K)
- K971601OLYMPIC BILI-BASSINET2Cleared 510(K)
- K971256DUO-LITE PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K962612BILIBED PHOTOTHERAPY LAMP2Cleared 510(K)
- K954611DRAGER PT4000 PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K940996OLYMPIC BILI-LITE2Cleared 510(K)
- K934946BILIBLANKET PLUS PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K931965MEDIX PHOTOTHERAPY LAMP2Cleared 510(K)
- K910571BILIBLANKET LIGHT METER2Cleared 510(K)
- K912908AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K903445OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR2Cleared 510(K)
- K902749OLYMPIC MINI BILI-LITE, MODEL 772Cleared 510(K)
- K901987OLYMPIC BILI-LITE-PAD(TM)2Cleared 510(K)
- K894129BILIBLANKET PHOTOTHERAPY DEVICE2Cleared 510(K)
- K892940PRECIOUS LITE MODEL 42242Cleared 510(K)
- K884133PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP2Cleared 510(K)
- K883779WALLABY(TM) BLANKET2Cleared 510(K)
- K882291RETROFIT BABY FACE SHIELD (RFS)2Cleared 510(K)
- K873700INSTITUTIONAL BILI LIGHT (IBL)2Cleared 510(K)
- K854122PRECIOUS LITE MODEL 42242Cleared 510(K)
- K850599HOME BILI LIGHTS-MODEL 1002Cleared 510(K)
- K850181AEQUITRON MED-7100 PHOTOTHERAPY LIGHT2Cleared 510(K)
- K834430OMNI INFANT PHOTOTHERAPY UNIT2Cleared 510(K)
- K834335AMEDA PHOTOTHERAPY LAMP FOR NEWBORN2Cleared 510(K)
- K840454PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO2Cleared 510(K)
- K832298BABY LIGHT DOSIMETER2Cleared 510(K)
- K830200MICROELISA MINIREADER II2Cleared 510(K)
- K813188INFANT PHOTOTHERAPY LIGHT2Cleared 510(K)
- K810953MODEL 533 PHOTOTHERAPY UNIT2Cleared 510(K)
- K802702NEONATAL PHOTOTHERAPY UNIT2Cleared 510(K)
- K791114BILI-DOSIMETER2Cleared 510(K)
- K771025PHOTOTHERAPY/PROCEDURE LAMP2Cleared 510(K)
- K760872PHOTOTHERAPY LIGHT2Cleared 510(K)
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BILISOFT PHOTOTHERAPY SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K053568
- 510(k) Type
- Traditional
- Applicant
- LUMITEX, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/17/2006
- Days to Decision
- 116 days
- Submission Type
- Summary