Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- MOCCushion, Flotation, Therapeutic2Product Code
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat2Product Code
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2Product Code
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat2Product Code
- QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser2Product Code
- QRAVirtual Reality Behavioral Therapy Device For Pain Relief2Product Code
- BXBExerciser, Powered1Product Code
- EGJDevice, Iontophoresis, Other Uses2Product Code
- HPHDiathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- IKWUtensil, Homemaking1Product Code
- IKXAid, Transfer1Product Code
- IKZBed, Patient Rotation, Powered2Product Code
- ILCUtensil, Eating1Product Code
- ILDAdaptor, Dressing1Product Code
- ILJBath, Hydro-Massage2Product Code
- ILKTransport, Patient, Powered2Product Code
- ILMBath, Sitz, Powered2Product Code
- ILOPack, Hot Or Cold, Water Circulating2Product Code
- ILSAdaptor, Hygiene1Product Code
- ILTAdaptor, Recreational1Product Code
- ILWAdaptor, Grooming1Product Code
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat2Product Code
- ILYLamp, Infrared, Therapeutic Heating2Product Code
- K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)2Cleared 510(K)
- K223642LED Lip Perfector, model: ZC-052Cleared 510(K)
- K221189OLIZ LTB-1000A2Cleared 510(K)
- K213524CytonPro-50002Cleared 510(K)
- K202028dermalux Flex MD2Cleared 510(K)
- K171087AXON IR Heat Lamp2Cleared 510(K)
- K163079HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System2Cleared 510(K)
- K170068Softcure 962Cleared 510(K)
- K162590Bashan TDP Heat Lamp2Cleared 510(K)
- K162763Vevazz LED Heat Lamp2Cleared 510(K)
- K160849WS(TM) Far-Infrared Therapy Unit, Model KP-B2102Cleared 510(K)
- K152087HeatLux Pro II2Cleared 510(K)
- K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 32Cleared 510(K)
- K152461The Time Machine Series Lasers2Cleared 510(K)
- K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System2Cleared 510(K)
- K153399LightStim Professional LED Bed2Cleared 510(K)
- K153389Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)2Cleared 510(K)
- K152280BioPhotas Celluma32Cleared 510(K)
- K150716Varaya Sport2Cleared 510(K)
- K150554NuBrilliance Light Pain Therapy2Cleared 510(K)
- K151521Phoenix Thera-Lase System2Cleared 510(K)
- K151333LightStim for Pain LED Belt2Cleared 510(K)
- K150466ZX2 Laser System2Cleared 510(K)
- K150175HeatLux Pro I2Cleared 510(K)
- K141892QK-SYSTEMIC THERAPEUTIC APPARATUS2Cleared 510(K)
- K142025NEUROLUMEN PN-10002Cleared 510(K)
- K1427223B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 2002Cleared 510(K)
- K142256Applied BioPhotonics Phototherapy System ABPT10032Cleared 510(K)
- K141861HILTHERA 4.02Cleared 510(K)
- K142340Infrared Therapy System2Cleared 510(K)
- K142215Power Twin21-50/Power Twin21-1002Cleared 510(K)
- K142078VELASII THERAPY LASER SYSTEM2Cleared 510(K)
- K141564OPTON PRO2Cleared 510(K)
- K140865INFRARED HEATING DEVICE2Cleared 510(K)
- K131080PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE2Cleared 510(K)
- K132016LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM2Cleared 510(K)
- K132529GALLIEON-1 MEDICAL LASER2Cleared 510(K)
- K134017GIGALASER2Cleared 510(K)
- K131113BIOPHOTAS CELLUMA2Cleared 510(K)
- K130168CL10009 IR LASER2Cleared 510(K)
- K131259LASER-STIM2Cleared 510(K)
- K123474AVANT LASER2Cleared 510(K)
- K130866BIOLIGHT BIODYNAM2Cleared 510(K)
- K1317973B LASER NEEDLE2Cleared 510(K)
- K123177STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM2Cleared 510(K)
- K123971CYNOSURE 1064NM DIODE LASER2Cleared 510(K)
- K121401TENDER TOUCH2Cleared 510(K)
- K122125ASA LASER SH12Cleared 510(K)
- K122237BIOPHOTAS LIFELIGHT2Cleared 510(K)
- K121363DIOWAVE LOW LEVEL COLD LASER SYSTEM2Cleared 510(K)
- K110558CS1000 LIGHT THERAPY DEVICE2Cleared 510(K)
- K120582HEATLUX2Cleared 510(K)
- K113668HEALITE II SYSTEM2Cleared 510(K)
- K121487LITECURE THERAPY COMPACT2Cleared 510(K)
- K120604K-LASER2Cleared 510(K)
- K112494VARAYA AR , VARAYA SPORT2Cleared 510(K)
- K120254THERASAGE HEATING PAD2Cleared 510(K)
- K113231WARP10,WARP752Cleared 510(K)
- K112016L-SER KO LAMP2Cleared 510(K)
- K113250DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE2Cleared 510(K)
- K111901ASA 'MPHI FAMILY DIODE LASER2Cleared 510(K)
- K110342YOLO CURVE2Cleared 510(K)
- K110721GAUNYING INFRARED LAMP2Cleared 510(K)
- K102375LUCIA2Cleared 510(K)
- K101893NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS2Cleared 510(K)
- K103511LITECURE THERAPY SYSTEM2Cleared 510(K)
- K101894HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT2Cleared 510(K)
- K101716HVR PAIN RELIEF DEVICE2Cleared 510(K)
- K101693GAUNYING INFRARED LAMP MODEL IL502Cleared 510(K)
- K102134MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM2Cleared 510(K)
- K101267PREMIO 10 MOXA2Cleared 510(K)
- K100213LUMANOSITY CELEBRITY, MODEL 2042Cleared 510(K)
- K093204INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM2Cleared 510(K)
- K102149GAUNYING INFRARED LAMP2Cleared 510(K)
- K101227BACK-TEK2Cleared 510(K)
- K090250ELECTRO-LIGHT THERAPY2Cleared 510(K)
- K092589THERMOTEX PLATINUM SYSTEM2Cleared 510(K)
- K091675LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER2Cleared 510(K)
- K091726NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 9802Cleared 510(K)
- K090008TANDA RESTORE, MODEL PTSCS2Cleared 510(K)
- K092222THERMAPULSE2Cleared 510(K)
- K091497K-LASER K-1200, MODEL 12 W2Cleared 510(K)
- K091158SCALAR WAVE LASER SYSTEM2Cleared 510(K)
- K091285AL T LASER, MODEL AVI HPLL-122Cleared 510(K)
- K083183AKLARUS PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K083580ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 13012Cleared 510(K)
- K081720PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS2Cleared 510(K)
- K082686MULTI-CHANNEL LASER THERAPY SYSTEM2Cleared 510(K)
- K082223NEUTROLUMENPN SYSTEM, MODEL 10002Cleared 510(K)
- K083595EZLASE2Cleared 510(K)
- K081962LAPEX BCS2Cleared 510(K)
- K081355BIOFLEX LD-R100 TREATMENT HEAD2Cleared 510(K)
- K083560EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X2Cleared 510(K)
- K073681NANOBEAM 940, MODEL 940-900-022Cleared 510(K)
- K081505THERAGEM PROFESSIONAL T10022Cleared 510(K)
- K081570DPL THERAPY SYSTEM2Cleared 510(K)
- K082969LUMINEX INFRARED LAMP SYSTEM2Cleared 510(K)
- K080786ML830TP2Cleared 510(K)
- K082707MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER2Cleared 510(K)
- K080102TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM2Cleared 510(K)
- K073352WEBERNEEDLE BASIC LASER2Cleared 510(K)
- K080465WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES2Cleared 510(K)
- K080689SPECTRA THERAPY SYSTEM A1000 LASER DEVICE2Cleared 510(K)
- K072399DEL SOL RED LIGHT THERAPY SYSTEM2Cleared 510(K)
- K080084CELL GEN LASER, MODEL CG-40002Cleared 510(K)
- K080318ALMA LASER NIR MODULE2Cleared 510(K)
- K072048LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE2Cleared 510(K)
- K070690THE LIFE VESSEL2Cleared 510(K)
- K071445TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS2Cleared 510(K)
- K070338RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS2Cleared 510(K)
- K070516POWERLASER2Cleared 510(K)
- K070974LIGHT RELIEF, MODEL LR150, LR2002Cleared 510(K)
- K070024THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE2Cleared 510(K)
- K063745MEDILASER, MODEL 10002Cleared 510(K)
- K063568HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL2Cleared 510(K)
- K070400LC THERAPY, MODEL LCT-10002Cleared 510(K)
- K062635MODEL 22002Cleared 510(K)
- K060792ILLUMIMED2Cleared 510(K)
- K061614TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS2Cleared 510(K)
- K060153ACUMED LASER, MODEL 10002Cleared 510(K)
- K052492AIRNERGY+STREAM2Cleared 510(K)
- K060191ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT2Cleared 510(K)
- K061080IR PRO 2502Cleared 510(K)
- K060134APOLLO IR HEAT LAMP SYSTEM2Cleared 510(K)
- K051875BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS2Cleared 510(K)
- K053376CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-88102Cleared 510(K)
- K051961WWMED, MODEL 4012Cleared 510(K)
- K053473MAESTRO MDTL LASER SYSTEM2Cleared 510(K)
- K052307BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM2Cleared 510(K)
- K053201CURAE'LASE CL1000 IR LASER SYSTEM2Cleared 510(K)
- K052814LUMINA 1600, 3300 AND 6600 SYSTEMS2Cleared 510(K)
- K052647CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55.2Cleared 510(K)
- K051548IRRADIA MID - LASER (S3)2Cleared 510(K)
- K051680DYNATRON DX2 TRACTION UNIT2Cleared 510(K)
- K052063HUANQIU HEATING LAMP2Cleared 510(K)
- K051537HILT FAMILY LASER: HILT I, HILT II, HILT III2Cleared 510(K)
- K051922ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M62Cleared 510(K)
- K051816LUMIWAVE 1X4 INFRARED THERAPY DEVICE2Cleared 510(K)
- K051681DERMILLUME RED, MODEL HR10002Cleared 510(K)
- K051261DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE2Cleared 510(K)
- K043055TERRAQUANT MQ2000 LASER THERAPY DEVICE2Cleared 510(K)
- K050370PALOMAR LUXIR HANDPIECE2Cleared 510(K)
- K043558XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A2Cleared 510(K)
- K043306SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR2Cleared 510(K)
- K051046PAINACEA MODEL XR8 INFRARED HEAT LAMP2Cleared 510(K)
- K043586LASER SYS*STIM 540, MODEL ME 5402Cleared 510(K)
- K050022MEDX HOME2Cleared 510(K)
- K050070K-LASER, MODELS 3,4,4D,6D2Cleared 510(K)
- K043317OMNILUX PLUS2Cleared 510(K)
- K042813BIOBEAM NARROW BAND LIGHT THERAPY DEVICES2Cleared 510(K)
- K041885BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS2Cleared 510(K)
- K041679COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT2Cleared 510(K)
- K042532BIOCARE SYSTEMS PREMIR 8182Cleared 510(K)
- K041364ML830 LASER SYSTEM2Cleared 510(K)
- K030275MB SYSTEM, BIOENERGY LIGHT THERAPY2Cleared 510(K)
- K042256IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE2Cleared 510(K)
- K042165CUTERA TABLETOP AESTHETIC PRODUCT2Cleared 510(K)
- K040662VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS2Cleared 510(K)
- K040729SOLARIS D890 THERAPY PROBE2Cleared 510(K)
- K040664OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-20042Cleared 510(K)
- K040679RICH-MAR AUTOPRISM INFRARED LAMP2Cleared 510(K)
- K033986MLT-1000 IR LASER SYSTEM2Cleared 510(K)
- K033923TH0R DDII IR LAMP SYSTEM2Cleared 510(K)
- K033555KENKOWAVE INFRARED PAIN TREATMENT SYSTEM2Cleared 510(K)
- K033768ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE2Cleared 510(K)
- K031612ALT LASER, MODEL VTR 752Cleared 510(K)
- K024027LIGHTWAVE INFRARED LAMPS LW10D AND LW30D2Cleared 510(K)
- K033035TLC MODELS ULK-H AND ULT-H INFRARED LAMPS2Cleared 510(K)
- K032787NEUROLASE, MODELS 150V, 150C, 10642Cleared 510(K)
- K032379QUASAR, MODEL MD212Cleared 510(K)
- K024361EM PROBE, EM PAD2Cleared 510(K)
- K032231MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER2Cleared 510(K)
- K032229QUANTUM WARP 10 LIGHT DELIVERY SYSTEM2Cleared 510(K)
- K024179PALOMAR LIGHTCUBE2Cleared 510(K)
- K023621BIOFLEX PROFESSIONAL THERAPY SYSTEM2Cleared 510(K)
- K022609SURGICAL PATIENT WARMER, MODEL PW820 JHU2Cleared 510(K)
- K022888ACUBEAM, SUPER NOVA, DIO2Cleared 510(K)
- K020851TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D2Cleared 510(K)
- K020464SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-36462Cleared 510(K)
- K020462SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-20182Cleared 510(K)
- K013197WS-501 HEAT LAMP2Cleared 510(K)
- K021956MHS MED LIGHT 10002Cleared 510(K)
- K020017MEDX 1000 SERIES2Cleared 510(K)
- K014208SSIR SYSTEM2Cleared 510(K)
- K011355BIOLIGHT PCD2Cleared 510(K)
- K012508MU PHOTONICS PAIN THERAPIST2Cleared 510(K)
- K003538TDP CQ-27 HEAT LAMP2Cleared 510(K)
- K001179SUPER NOVA, ACUBEAM2Cleared 510(K)
- K001056OLYMPIC WARM-UP2Cleared 510(K)
- K993684SPINAL PAD2Cleared 510(K)
- K993685BIOPACK2Cleared 510(K)
- K993686LIGHT PATCH2Cleared 510(K)
- K993123QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B2Cleared 510(K)
- K990233ST-302 INFRAREX2Cleared 510(K)
- K991503SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-362Cleared 510(K)
- K982636PATIENT WARMER- MODEL PW8102Cleared 510(K)
- K982546PHASER-20002Cleared 510(K)
- K974468PHOTONIC STIMULATOR2Cleared 510(K)
- K980607DERMATHERM 1002Cleared 510(K)
- K964397THERAPIK2Cleared 510(K)
- K970592N/A2Cleared 510(K)
- K970590N/A2Cleared 510(K)
- K954577WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS2Cleared 510(K)
- K963728THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS2Cleared 510(K)
- K960036FIRARD II/ TDP LAMP2Cleared 510(K)
- K941675TDP THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS2Cleared 510(K)
- K935982SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS2Cleared 510(K)
- K935995HAND-HELD HEAT APPLICATOR2Cleared 510(K)
- K931261SPECTROPAD SYSTEM2Cleared 510(K)
- K933584SACRED CRANE TDP2Cleared 510(K)
- K932881OLYMPIC WARM-LAMP2Cleared 510(K)
- K925054INFRARED LAMP2Cleared 510(K)
- K923254THERABEAM INFRARED HEAT LAMP2Cleared 510(K)
- K922900INFRARED LAMP2Cleared 510(K)
- K913973INFRARED HEAT LAMPS & MASSAGER MODEL NH-2132Cleared 510(K)
- K913880INFRARED HEAT LAMP MODEL NH-2022Cleared 510(K)
- K913856INFRARED HEAT LAMP MODEL NH-2012Cleared 510(K)
- K902803A PHYSIOTHERAPY APPARATUS2Cleared 510(K)
- K900384INFRAVIB MASSAGER - MODEL PR-10002Cleared 510(K)
- K890585INFRARED HEX2Cleared 510(K)
- K890586INFRARED DELUXE2Cleared 510(K)
- K890556TDP INFRARED HEAT LAMP2Cleared 510(K)
- K875052TDP, LARK BRAND AND MIT LAMP2Cleared 510(K)
- K871179OPN XII UL2Cleared 510(K)
- K864714INFRALUX HEAT LAMP2Cleared 510(K)
- K854151HOMECARE CLINICS INFRAHEAT #2302Cleared 510(K)
- K850852INFRARAX DEVICE2Cleared 510(K)
- ILZAccessories, Traction1Product Code
- IMAPack, Heat, Moist1Product Code
- IMBCabinet, Moist Steam2Product Code
- IMCBath, Paraffin2Product Code
- IMDPack, Hot Or Cold, Disposable1Product Code
- IMEPack, Hot Or Cold, Reusable1Product Code
- IMFUnit, Chilling1Product Code
- INXBed, Air Fluidized2Product Code
- INYBed, Patient Rotation, Manual1Product Code
- IOADiathermy, Microwave, For Use In Applying Therapeutic Deep Heat2Product Code
- IOBLamp, Infrared, Non Heating2Product Code
- IODComponents, Exercise1Product Code
- IOEBars, Parallel, Exercise1Product Code
- IOGTreadmill, Mechanical1Product Code
- IOLTreadmill, Powered1Product Code
- IONExerciser, Non-Measuring1Product Code
- IOQBed, Flotation Therapy, Powered2Product Code
- IPFStimulator, Muscle, Powered2Product Code
- IRNDevice, Warning, Overload, External Limb, Powered2Product Code
- IROVibrator, Therapeutic1Product Code
- IRPMassager, Powered Inflatable Tube2Product Code
- IRQUnit, Heating, Powered1Product Code
- IRRBars, Parallel, Powered1Product Code
- IRSHead Halter, Traction1Product Code
- IRTPad, Heating, Powered2Product Code
- ISAMassager, Therapeutic, Electric1Product Code
- ISDExerciser, Measuring2Product Code
- ITHEquipment, Traction, Powered2Product Code
- JFAExerciser, Finger, Powered1Product Code
- JFBTable, Physical Therapy, Multi Function2Product Code
- KNLBoard, Scooter, Prone1Product Code
- KNMDevice, Pressure Applying1Product Code
- KTBDevice, Iontophoresis, Specific Uses2Product Code
- KTCBath, Sitz, Nonpowered1Product Code
- LBGDevice, Fluidized Therapy, Dry Heat2Product Code
- LSBUnit, Fluidotherapy2Product Code
- LXFDiathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- LXJInteractive Rehabilitation Exercise Devices2Product Code
- LYGMassager, Therapeutic, Manual1Product Code
- MPOInfant Heel Warmer (Chemical Heat Pack)1Product Code
- NGXStimulator, Muscle, Powered, For Muscle Conditioning2Product Code
- NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy2Product Code
- NYYStimulator, Muscle, Powered, With Limited Output, For Rehabilitation2Product Code
- NYZStimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning2Product Code
- OMWAdhesive Backed Thermal Skin Patches1Product Code
- OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature2Product Code
- PCDPowered Stairway Chair Lift2Product Code
- PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat2Product Code
- PHWCold Pack And Vibrating Massager1Product Code
- PKSExerciser, Non-Measuring For Stroke Rehabilitation1Product Code
- PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain2Product Code
- QKCInteractive Rehabilitation Exercise Device, Prescription Use2Product Code
- QKDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use2Product Code
- QTCAdult Portable Bed Rails For Medical Purposes1Product Code
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K153389
- 510(k) Type
- Traditional
- Applicant
- IN LIGHT WELLNESS SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/30/2016
- Days to Decision
- 128 days
- Submission Type
- Summary