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LEM
Human Lyophilized Dura Mater
2
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LGW
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
3
Product Code
LHY
Electrode, Stabilized Epidural Spinal
3
Product Code
LII
Monitor, Intracranial Pressure, Implanted
3
Product Code
LKW
Laser, Neurosurgical
3
Product Code
K
87
5042
ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
3
Cleared 510(K)
K
88
0172
MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
3
Cleared 510(K)
K
86
4166
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
3
Cleared 510(K)
K
85
3580
MEDILAS 2
3
Cleared 510(K)
K
84
4440
MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL
3
Cleared 510(K)
LLE
Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
3
Product Code
LLF
Laser, Neurosurgical, Argon
3
Product Code
LLP
Laser For Pain Therapy
3
Product Code
LME
Monitor, Blood-Flow, Cerebral, Thermal Diffusion
3
Product Code
LQD
Recorder, Attention Task Performance
U
Product Code
LYI
Stimulator, Subcortical, Implanted For Epilepsy
3
Product Code
LYJ
Stimulator, Autonomic Nerve, Implanted For Epilepsy
3
Product Code
MBX
Stimulator, Thalamic, Epilepsy, Implanted
3
Product Code
BWK
Stimulator, Electro-Acupuncture
U
Product Code
KGF
Adhesive, Tissue For Aneurysmorrhaphy
3
Product Code
QCF
Neuromuscular Tongue Stimulator To Treat Motor Deficits
2
Product Code
KGG
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
3
Product Code
LBK
Device, Neurosurgical Fragmentation And Aspiration
U
Product Code
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
2
Product Code
MFE
Agent, Injectable, Embolic
3
Product Code
MFR
Stimulator, Brain, Implanted, For Behavior Modification
F
Product Code
MHY
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
3
Product Code
MHZ
Stimulator, Vestibular Acceleration, Therapeutic
3
Product Code
MKD
Stimulator, Functional Walking Neuromuscular, Non-Invasive
3
Product Code
MLQ
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
3
Product Code
MRU
Implanted Subcortical Electrical Stimulator (Motor Disorders)
F
Product Code
MUZ
Stimulator, Autonomic Nerve, Implanted (Depression)
3
Product Code
MVV
Device, Acupressure
U
Product Code
MXM
Cap, Cooling (Infants)
3
Product Code
NHL
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
3
Product Code
NJE
Intracranial Neurovascular Stent
F
Product Code
NPE
Material, Embolization, Neurovascular, Polymerizing Or Precipitating
3
Product Code
NQR
Sealant, Dural
3
Product Code
NZK
Stimulator, Low Electric Field, Tumor Treatment
3
Product Code
OBA
Polymerizing, Neurovascular Embolization Material
F
Product Code
OLM
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
F
Product Code
OPR
Intrasaccular Flow Disruption Device
3
Product Code
OUT
Intracranial Aneurysm Flow Diverter
3
Product Code
OUU
Polymeric Neurovascular Embolization
F
Product Code
OVC
Headframe
N
Product Code
OZJ
Inhibitor, Postoperative Fibrosis (Adhesion Barrier)
N
Product Code
PAX
Surgical Kit
F
Product Code
PCQ
Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)
N
Product Code
PFN
Implanted Brain Stimulator For Epilepsy
3
Product Code
PJS
Stimulator, Electrical, Implanted, For Essential Tremor
3
Product Code
PMP
Dorsal Root Ganglion Stimulator For Pain Relief
3
Product Code
POH
Mr-Guided Focused Ultrasound System
3
Product Code
QCA
Intracranial Coil-Assist Stent
3
Product Code
QLK
Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
3
Product Code
QRB
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
3
Product Code
QSL
Brain Temperature Measurement System
2
Product Code
QSQ
Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
2
Product Code
QWD
Stimulator, Nerve, For Restless Legs Syndrome
2
Product Code
QTK
Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device
F
Product Code
QWT
Prognostic Assessment Software Of Mild Cognitive Impairment
2
Product Code
Submissions with No Product Code
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
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Subpart F—Physical Medicine Therapeutic Devices
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Subpart F—Therapeutic Devices
CFR Sub-Part
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Last synced on 16 August 2024 at 11:05 pm
NE
/
NE-misc
/
LKW
/
K864166
View Source
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864166
510(k) Type
Traditional
Applicant
WECK SURGICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/10/1987
Days to Decision
110 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
LEM
Human Lyophilized Dura Mater
LGW
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
LHY
Electrode, Stabilized Epidural Spinal
LII
Monitor, Intracranial Pressure, Implanted
LKW
Laser, Neurosurgical
K
87
5042
ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
K
88
0172
MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.
K
86
4166
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
K
85
3580
MEDILAS 2
K
84
4440
MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL
LLE
Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease
LLF
Laser, Neurosurgical, Argon
LLP
Laser For Pain Therapy
LME
Monitor, Blood-Flow, Cerebral, Thermal Diffusion
LQD
Recorder, Attention Task Performance
LYI
Stimulator, Subcortical, Implanted For Epilepsy
LYJ
Stimulator, Autonomic Nerve, Implanted For Epilepsy
MBX
Stimulator, Thalamic, Epilepsy, Implanted
BWK
Stimulator, Electro-Acupuncture
KGF
Adhesive, Tissue For Aneurysmorrhaphy
QCF
Neuromuscular Tongue Stimulator To Treat Motor Deficits
KGG
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
LBK
Device, Neurosurgical Fragmentation And Aspiration
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
MFE
Agent, Injectable, Embolic
MFR
Stimulator, Brain, Implanted, For Behavior Modification
MHY
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
MHZ
Stimulator, Vestibular Acceleration, Therapeutic
MKD
Stimulator, Functional Walking Neuromuscular, Non-Invasive
MLQ
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
MRU
Implanted Subcortical Electrical Stimulator (Motor Disorders)
MUZ
Stimulator, Autonomic Nerve, Implanted (Depression)
MVV
Device, Acupressure
MXM
Cap, Cooling (Infants)
NHL
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
NJE
Intracranial Neurovascular Stent
NPE
Material, Embolization, Neurovascular, Polymerizing Or Precipitating
NQR
Sealant, Dural
NZK
Stimulator, Low Electric Field, Tumor Treatment
OBA
Polymerizing, Neurovascular Embolization Material
OLM
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)
OPR
Intrasaccular Flow Disruption Device
OUT
Intracranial Aneurysm Flow Diverter
OUU
Polymeric Neurovascular Embolization
OVC
Headframe
OZJ
Inhibitor, Postoperative Fibrosis (Adhesion Barrier)
PAX
Surgical Kit
PCQ
Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)
PFN
Implanted Brain Stimulator For Epilepsy
PJS
Stimulator, Electrical, Implanted, For Essential Tremor
PMP
Dorsal Root Ganglion Stimulator For Pain Relief
POH
Mr-Guided Focused Ultrasound System
QCA
Intracranial Coil-Assist Stent
QLK
Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
QRB
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
QSL
Brain Temperature Measurement System
QSQ
Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
QWD
Stimulator, Nerve, For Restless Legs Syndrome
QTK
Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device
QWT
Prognostic Assessment Software Of Mild Cognitive Impairment
Submissions with No Product Code
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
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
/
NE-misc
/
LKW
/
K864166
View Source
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864166
510(k) Type
Traditional
Applicant
WECK SURGICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/10/1987
Days to Decision
110 days