FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
GXO
Strip, Craniosynostosis, Preformed
2
Product Code
GXP
Methyl Methacrylate For Cranioplasty
2
Product Code
GXQ
Dura Substitute
2
Product Code
GXR
Cover, Burr Hole
2
Product Code
GXT
Monitor, Lesion Temperature
2
Product Code
GWO
Plate, Cranioplasty, Preformed, Alterable
2
Product Code
GXC
Device, Electroconvulsive Therapy
3
Product Code
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
2
Product Code
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
3
Product Code
GZA
Implanted Cerebellar Stimulator
3
Product Code
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
2
Product Code
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
2
Product Code
GZI
Stimulator, Neuromuscular, External Functional
2
Product Code
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
2
Product Code
HAX
Tong, Skull For Traction
2
Product Code
HBP
Clip, Implanted Malleable
2
Product Code
HBW
Fastener, Plate, Cranioplasty
2
Product Code
HBZ
Catheter, Intravascular Occluding
3
Product Code
HCB
Device, Aversive Conditioning
2
Product Code
HCC
Device, Biofeedback
2
Product Code
HCE
Clamp, Carotid Artery
2
Product Code
HCG
Device, Neurovascular Embolization
2
Product Code
HCH
Clip, Aneurysm
2
Product Code
JXG
Shunt, Central Nervous System And Components
2
Product Code
JXH
Methyl Methacrylate For Aneurysmorrhaphy
2
Product Code
JXI
Cuff, Nerve
2
Product Code
JXK
Cranial Electrotherapy Stimulator To Treat Depression
3
Product Code
JXL
Block, Bite
2
Product Code
LEL
Device, Sleep Assessment
2
Product Code
LHG
Electrode, Spinal Epidural
2
Product Code
LIH
Interferential Current Therapy
2
Product Code
MVA
Orthosis, Cranial
2
Product Code
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
2
Product Code
MZQ
Balloon, Detachable, For Neurovascular Occlusion
2
Product Code
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
2
Product Code
K
24
0564
NuFACE® FIX+
2
Cleared 510(K)
K
23
2242
BEAR 2 Body
2
Cleared 510(K)
K
23
3667
Facial Toning device (UIC-189); Facial Toning device (UIC-589)
2
Cleared 510(K)
K
23
3525
MF SC Facial Toning System
2
Cleared 510(K)
K
23
3010
Beagank 4T Plus
2
Cleared 510(K)
K
23
2001
Nu Skin RenuSpa iO
2
Cleared 510(K)
K
23
0459
C.C. Life 21
2
Cleared 510(K)
K
23
2172
BTL-785BNF Handpiece
2
Cleared 510(K)
K
22
0198
Medi Lift PLUS
2
Cleared 510(K)
K
23
0506
PureLift Pro Edition
2
Cleared 510(K)
K
21
3078
Myolift QT
2
Cleared 510(K)
K
22
1443
PureLift Pro Plus
2
Cleared 510(K)
K
21
4100
Luminice
2
Cleared 510(K)
K
21
1055
Microcurrent device (Model: HBR2-1)
2
Cleared 510(K)
K
21
2238
TheraFace Microcurrent
2
Cleared 510(K)
K
21
2342
ZIIP+ Device
2
Cleared 510(K)
K
19
1951
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
2
Cleared 510(K)
K
20
1906
Trinity ELE Plus and Trinity ELE Plus Pro
2
Cleared 510(K)
K
20
1680
NuFACE Mini Plus
2
Cleared 510(K)
K
20
1782
NuFace Trinity Plus Device
2
Cleared 510(K)
K
19
2077
Tua Face Fitness / Tua Trend Face
2
Cleared 510(K)
K
20
0803
BEAR and BEAR mini
2
Cleared 510(K)
K
19
1672
NuFACE Mini Device
2
Cleared 510(K)
K
19
0269
PureLift
2
Cleared 510(K)
K
18
3189
Ultra OTC Facial Toning System
2
Cleared 510(K)
K
18
2424
NuFACE FIX Skin Toning Device
2
Cleared 510(K)
K
18
1008
NuFACE Trinity
2
Cleared 510(K)
K
18
1062
Ultra Facial Toning System
2
Cleared 510(K)
K
17
3093
TAMA BEMS device
2
Cleared 510(K)
K
17
1821
2 Face / Face Evolution
2
Cleared 510(K)
K
16
3550
Pobling MIITY 2
2
Cleared 510(K)
K
16
2652
Smart Photon Micro-current Device, Model: EP-300
2
Cleared 510(K)
K
17
1647
BeneLife Premium Facial Treatment Pack, Model: QZ0701A
2
Cleared 510(K)
K
17
1588
NuBODY Skin Toning Device
2
Cleared 510(K)
K
16
3470
Galvanic Spa, Model: SKB-1405
2
Cleared 510(K)
K
16
1484
ZIIP Device
2
Cleared 510(K)
K
16
2106
Micro-current Wrinkle Reduction Facial service, model EP-400
2
Cleared 510(K)
K
15
2199
RejuvatoneMD
2
Cleared 510(K)
K
15
0826
Nutra Face Lift Model PE8050
2
Cleared 510(K)
K
15
0077
SonicLift
2
Cleared 510(K)
K
14
2794
Everyway Facial MENS
2
Cleared 510(K)
K
13
0065
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
2
Cleared 510(K)
K
13
3823
NUFACE MINI DEVICE
2
Cleared 510(K)
K
13
1251
TRINITY ELE
2
Cleared 510(K)
K
12
2711
FACIAL SPA
2
Cleared 510(K)
K
12
0511
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
2
Cleared 510(K)
K
11
2351
ULTRA BEAUTY
2
Cleared 510(K)
K
11
3724
ELECTROPULSE-COSMETIC
2
Cleared 510(K)
K
10
2494
THE BUZZ FACIAL TONING SYSTEM
2
Cleared 510(K)
K
10
3031
BMR FACE
2
Cleared 510(K)
K
10
3472
NUFACE PLUS
2
Cleared 510(K)
K
07
1573
RUGALIFT, MODEL# V.2.1
2
Cleared 510(K)
K
07
0250
NUTRITONE FACIAL BEAUTY SYSTEM
2
Cleared 510(K)
K
07
0217
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
2
Cleared 510(K)
K
07
2260
NUFACE, MODEL NU-4003
2
Cleared 510(K)
K
04
0871
FACEMASTER FACIAL TONING SYSTEM
2
Cleared 510(K)
K
01
1935
REJUVENIQUE MODEL #RJV10
2
Cleared 510(K)
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
2
Product Code
NUF
Catheter, Neurovasculature, Occluding Balloon
3
Product Code
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
2
Product Code
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
2
Product Code
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
2
Product Code
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
2
Product Code
OAN
Orthosis, Cranial, Laser Scan
2
Product Code
OBP
Transcranial Magnetic Stimulator
2
Product Code
OBV
Eating Disorder Conditioning Tool
2
Product Code
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
2
Product Code
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
2
Product Code
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
2
Product Code
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
2
Product Code
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
F
Product Code
PBJ
Cranial Distraction System
2
Product Code
PCB
External Cerebrospinal Fluid (Csf) Diversion
2
Product Code
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
2
Product Code
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
2
Product Code
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
2
Product Code
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
2
Product Code
PLU
Thermal System For Insomnia
2
Product Code
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
2
Product Code
PUU
Temporary Coil Embolization Assist Device
2
Product Code
PVL
Endoscopic Shunt Placement Kit
2
Product Code
PVO
Lumbar Drainage Catheter Kit
2
Product Code
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
2
Product Code
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
2
Product Code
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
2
Product Code
QAR
Thermal Vestibular Stimulator For Headache
2
Product Code
QBC
External Upper Limb Tremor Stimulator
2
Product Code
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
2
Product Code
QFD
Tens For Sinus Pain
2
Product Code
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
2
Product Code
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
2
Product Code
QGL
Transcutaneous Nerve Stimulator For Adhd
2
Product Code
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
2
Product Code
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
2
Product Code
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
2
Product Code
QQC
Brain Stimulation Programming Planning Software.
2
Product Code
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
2
Product Code
OVP
Vibratory Counter-Stimulation
2
Product Code
QVO
Computerized Behavioral Therapy Device For Insomnia
2
Product Code
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
2
Product Code
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
2
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
NE
/
subpart-f—neurological-therapeutic-devices
/
NFO
/
K201680
View Source
NuFACE Mini Plus
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201680
510(k) Type
Abbreviated
Applicant
Carole Cole Company
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/19/2021
Days to Decision
242 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
GXO
Strip, Craniosynostosis, Preformed
GXP
Methyl Methacrylate For Cranioplasty
GXQ
Dura Substitute
GXR
Cover, Burr Hole
GXT
Monitor, Lesion Temperature
GWO
Plate, Cranioplasty, Preformed, Alterable
GXC
Device, Electroconvulsive Therapy
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
GZA
Implanted Cerebellar Stimulator
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZI
Stimulator, Neuromuscular, External Functional
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
HAX
Tong, Skull For Traction
HBP
Clip, Implanted Malleable
HBW
Fastener, Plate, Cranioplasty
HBZ
Catheter, Intravascular Occluding
HCB
Device, Aversive Conditioning
HCC
Device, Biofeedback
HCE
Clamp, Carotid Artery
HCG
Device, Neurovascular Embolization
HCH
Clip, Aneurysm
JXG
Shunt, Central Nervous System And Components
JXH
Methyl Methacrylate For Aneurysmorrhaphy
JXI
Cuff, Nerve
JXK
Cranial Electrotherapy Stimulator To Treat Depression
JXL
Block, Bite
LEL
Device, Sleep Assessment
LHG
Electrode, Spinal Epidural
LIH
Interferential Current Therapy
MVA
Orthosis, Cranial
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
MZQ
Balloon, Detachable, For Neurovascular Occlusion
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
K
24
0564
NuFACE® FIX+
K
23
2242
BEAR 2 Body
K
23
3667
Facial Toning device (UIC-189); Facial Toning device (UIC-589)
K
23
3525
MF SC Facial Toning System
K
23
3010
Beagank 4T Plus
K
23
2001
Nu Skin RenuSpa iO
K
23
0459
C.C. Life 21
K
23
2172
BTL-785BNF Handpiece
K
22
0198
Medi Lift PLUS
K
23
0506
PureLift Pro Edition
K
21
3078
Myolift QT
K
22
1443
PureLift Pro Plus
K
21
4100
Luminice
K
21
1055
Microcurrent device (Model: HBR2-1)
K
21
2238
TheraFace Microcurrent
K
21
2342
ZIIP+ Device
K
19
1951
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
K
20
1906
Trinity ELE Plus and Trinity ELE Plus Pro
K
20
1680
NuFACE Mini Plus
K
20
1782
NuFace Trinity Plus Device
K
19
2077
Tua Face Fitness / Tua Trend Face
K
20
0803
BEAR and BEAR mini
K
19
1672
NuFACE Mini Device
K
19
0269
PureLift
K
18
3189
Ultra OTC Facial Toning System
K
18
2424
NuFACE FIX Skin Toning Device
K
18
1008
NuFACE Trinity
K
18
1062
Ultra Facial Toning System
K
17
3093
TAMA BEMS device
K
17
1821
2 Face / Face Evolution
K
16
3550
Pobling MIITY 2
K
16
2652
Smart Photon Micro-current Device, Model: EP-300
K
17
1647
BeneLife Premium Facial Treatment Pack, Model: QZ0701A
K
17
1588
NuBODY Skin Toning Device
K
16
3470
Galvanic Spa, Model: SKB-1405
K
16
1484
ZIIP Device
K
16
2106
Micro-current Wrinkle Reduction Facial service, model EP-400
K
15
2199
RejuvatoneMD
K
15
0826
Nutra Face Lift Model PE8050
K
15
0077
SonicLift
K
14
2794
Everyway Facial MENS
K
13
0065
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
K
13
3823
NUFACE MINI DEVICE
K
13
1251
TRINITY ELE
K
12
2711
FACIAL SPA
K
12
0511
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
K
11
2351
ULTRA BEAUTY
K
11
3724
ELECTROPULSE-COSMETIC
K
10
2494
THE BUZZ FACIAL TONING SYSTEM
K
10
3031
BMR FACE
K
10
3472
NUFACE PLUS
K
07
1573
RUGALIFT, MODEL# V.2.1
K
07
0250
NUTRITONE FACIAL BEAUTY SYSTEM
K
07
0217
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
K
07
2260
NUFACE, MODEL NU-4003
K
04
0871
FACEMASTER FACIAL TONING SYSTEM
K
01
1935
REJUVENIQUE MODEL #RJV10
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NUF
Catheter, Neurovasculature, Occluding Balloon
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
OAN
Orthosis, Cranial, Laser Scan
OBP
Transcranial Magnetic Stimulator
OBV
Eating Disorder Conditioning Tool
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
PBJ
Cranial Distraction System
PCB
External Cerebrospinal Fluid (Csf) Diversion
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
PLU
Thermal System For Insomnia
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
PUU
Temporary Coil Embolization Assist Device
PVL
Endoscopic Shunt Placement Kit
PVO
Lumbar Drainage Catheter Kit
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
QAR
Thermal Vestibular Stimulator For Headache
QBC
External Upper Limb Tremor Stimulator
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QFD
Tens For Sinus Pain
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
QGL
Transcutaneous Nerve Stimulator For Adhd
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QQC
Brain Stimulation Programming Planning Software.
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
OVP
Vibratory Counter-Stimulation
QVO
Computerized Behavioral Therapy Device For Insomnia
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-f—neurological-therapeutic-devices
/
NFO
/
K201680
View Source
NuFACE Mini Plus
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201680
510(k) Type
Abbreviated
Applicant
Carole Cole Company
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/19/2021
Days to Decision
242 days
Submission Type
Summary