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
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- K240564NuFACE® FIX+2Cleared 510(K)
- K232242BEAR 2 Body2Cleared 510(K)
- K233667Facial Toning device (UIC-189); Facial Toning device (UIC-589)2Cleared 510(K)
- K233525MF SC Facial Toning System2Cleared 510(K)
- K233010Beagank 4T Plus2Cleared 510(K)
- K232001Nu Skin RenuSpa iO2Cleared 510(K)
- K230459C.C. Life 212Cleared 510(K)
- K232172BTL-785BNF Handpiece2Cleared 510(K)
- K220198Medi Lift PLUS2Cleared 510(K)
- K230506PureLift Pro Edition2Cleared 510(K)
- K213078Myolift QT2Cleared 510(K)
- K221443PureLift Pro Plus2Cleared 510(K)
- K214100Luminice2Cleared 510(K)
- K211055Microcurrent device (Model: HBR2-1)2Cleared 510(K)
- K212238TheraFace Microcurrent2Cleared 510(K)
- K212342ZIIP+ Device2Cleared 510(K)
- K191951Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device2Cleared 510(K)
- K201906Trinity ELE Plus and Trinity ELE Plus Pro2Cleared 510(K)
- K201680NuFACE Mini Plus2Cleared 510(K)
- K201782NuFace Trinity Plus Device2Cleared 510(K)
- K192077Tua Face Fitness / Tua Trend Face2Cleared 510(K)
- K200803BEAR and BEAR mini2Cleared 510(K)
- K191672NuFACE Mini Device2Cleared 510(K)
- K190269PureLift2Cleared 510(K)
- K183189Ultra OTC Facial Toning System2Cleared 510(K)
- K182424NuFACE FIX Skin Toning Device2Cleared 510(K)
- K181008NuFACE Trinity2Cleared 510(K)
- K181062Ultra Facial Toning System2Cleared 510(K)
- K173093TAMA BEMS device2Cleared 510(K)
- K1718212 Face / Face Evolution2Cleared 510(K)
- K163550Pobling MIITY 22Cleared 510(K)
- K162652Smart Photon Micro-current Device, Model: EP-3002Cleared 510(K)
- K171647BeneLife Premium Facial Treatment Pack, Model: QZ0701A2Cleared 510(K)
- K171588NuBODY Skin Toning Device2Cleared 510(K)
- K163470Galvanic Spa, Model: SKB-14052Cleared 510(K)
- K161484ZIIP Device2Cleared 510(K)
- K162106Micro-current Wrinkle Reduction Facial service, model EP-4002Cleared 510(K)
- K152199RejuvatoneMD2Cleared 510(K)
- K150826Nutra Face Lift Model PE80502Cleared 510(K)
- K150077SonicLift2Cleared 510(K)
- K142794Everyway Facial MENS2Cleared 510(K)
- K130065BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE2Cleared 510(K)
- K133823NUFACE MINI DEVICE2Cleared 510(K)
- K131251TRINITY ELE2Cleared 510(K)
- K122711FACIAL SPA2Cleared 510(K)
- K120511AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM2Cleared 510(K)
- K112351ULTRA BEAUTY2Cleared 510(K)
- K113724ELECTROPULSE-COSMETIC2Cleared 510(K)
- K102494THE BUZZ FACIAL TONING SYSTEM2Cleared 510(K)
- K103031BMR FACE2Cleared 510(K)
- K103472NUFACE PLUS2Cleared 510(K)
- K071573RUGALIFT, MODEL# V.2.12Cleared 510(K)
- K070250NUTRITONE FACIAL BEAUTY SYSTEM2Cleared 510(K)
- K070217INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE2Cleared 510(K)
- K072260NUFACE, MODEL NU-40032Cleared 510(K)
- K040871FACEMASTER FACIAL TONING SYSTEM2Cleared 510(K)
- K011935REJUVENIQUE MODEL #RJV102Cleared 510(K)
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- SCPComputerized Behavioral Therapy Device For Anxiety Disorders2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- 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
Luminice
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K214100
- 510(k) Type
- Traditional
- Applicant
- Premier North America Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/24/2022
- Days to Decision
- 57 days
- Submission Type
- Summary