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Innolitics
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Cardiovascular
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Chemistry
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Dental
Review Panel
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Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
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Hematology
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Immunology
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Microbiology
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Neurology
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Obstetrical and Gynecological
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Ophthalmic
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Orthopedic
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Pathology
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Physical Medicine
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Radiology
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General and Plastic Surgery
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Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
NZY
Light, Lymphedema Reduction, Low Energy
2
Product Code
OAP
Laser, Comb, Hair
2
Product Code
K
24
2363
HIGHERDOSE Red Light Hat (HG-120K)
2
Cleared 510(K)
K
24
1342
Hair Growth Comb (SZ-23,SZ-23A)
2
Cleared 510(K)
K
24
2620
Breo Laser Hair Growth Comb (Scalp 3L)
2
Cleared 510(K)
K
24
0472
PBM Hair Therapy Cap
2
Cleared 510(K)
K
24
0689
Robin's Egg
2
Cleared 510(K)
K
24
2441
Revian Lyte (10011)
2
Cleared 510(K)
K
24
0456
Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
2
Cleared 510(K)
K
24
0064
Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
2
Cleared 510(K)
K
23
2356
Laser Cap, Model: Hat-01
2
Cleared 510(K)
K
23
1321
Nooance Led And Laser Helmet
2
Cleared 510(K)
K
23
1153
Neuhat Hair Growth System; ibeauty.com Laser Cap
2
Cleared 510(K)
K
22
2790
F65 Laser System
2
Cleared 510(K)
K
23
0134
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
2
Cleared 510(K)
K
23
0597
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
2
Cleared 510(K)
K
22
3862
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
2
Cleared 510(K)
K
23
0336
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
2
Cleared 510(K)
K
22
2477
Hair Growth Device
2
Cleared 510(K)
K
22
2364
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
2
Cleared 510(K)
K
22
2081
ID-510 iRestore Elite
2
Cleared 510(K)
K
21
3789
Intelligence LaserComb
2
Cleared 510(K)
K
21
3027
Laser Hair Growth Comb
2
Cleared 510(K)
K
21
3025
Laser hair growth helmet
2
Cleared 510(K)
K
22
0543
Auxo A300, A150 and APod
2
Cleared 510(K)
K
21
3447
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
2
Cleared 510(K)
K
21
3094
ID-500 iRestore Hair Growth System
2
Cleared 510(K)
K
21
1192
Grivamax Family of Lasers, Models 272 and 148
2
Cleared 510(K)
K
21
1038
Biophotas Celluma RESTORE
2
Cleared 510(K)
K
21
0169
Hair Growth Device
2
Cleared 510(K)
K
20
3826
LaserCap Family of Lasers 300, 224, 120 & 80
2
Cleared 510(K)
K
20
2983
easy Hairfull
2
Cleared 510(K)
K
20
2631
iHelmet Laser Comb
2
Cleared 510(K)
K
19
3008
Tricoglam Home Use
2
Cleared 510(K)
K
20
1854
CAPOGEN Laser Cap
2
Cleared 510(K)
K
20
0464
LG Pra. L Derma LD Scalp Care
2
Cleared 510(K)
K
20
0929
Hair Growth System
2
Cleared 510(K)
K
19
2552
Irradiation Cosmetic Device
2
Cleared 510(K)
K
19
3667
Shapiro MD model laser 272
2
Cleared 510(K)
K
19
2585
Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
2
Cleared 510(K)
K
19
0467
iHelmet Hair Growth System
2
Cleared 510(K)
K
19
2627
Laser Hair Growth Cap
2
Cleared 510(K)
K
19
1754
Hair Growth System
2
Cleared 510(K)
K
19
2425
Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
2
Cleared 510(K)
K
19
2012
Capillus 112, Capillus 244
2
Cleared 510(K)
K
19
1154
Hair Boom 69
2
Cleared 510(K)
K
19
0685
Hair Growth System
2
Cleared 510(K)
K
18
3417
iRestore Professional 282
2
Cleared 510(K)
K
18
3329
Laser Hair Therapy
2
Cleared 510(K)
K
18
2562
Hair Boom 69
2
Cleared 510(K)
K
18
2501
Hair Laser Headband
2
Cleared 510(K)
K
18
1878
Kiierr 272 Laser, Kiierr 148 Laser
2
Cleared 510(K)
K
18
1308
SuperGrow 272, Ultimate 272
2
Cleared 510(K)
K
18
1253
Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
2
Cleared 510(K)
K
18
0885
HairMax Laser
2
Cleared 510(K)
K
18
0617
Hair Up
2
Cleared 510(K)
K
18
0460
Theradome LH40
2
Cleared 510(K)
K
17
3846
DermaScalp Laser Cap
2
Cleared 510(K)
K
17
3729
REVIAN RED
2
Cleared 510(K)
K
17
3678
Diode Laser Cap
2
Cleared 510(K)
K
17
1835
Irradiation Aesthetic Device
2
Cleared 510(K)
K
17
3843
illumiflow 148 Laser Cap
2
Cleared 510(K)
K
17
1775
Theradome LH80 PRO
2
Cleared 510(K)
K
17
2968
Hair Up
2
Cleared 510(K)
K
17
2982
SuperGrow 272, Ultimate 272
2
Cleared 510(K)
K
17
1895
Grivamax Hair Growth System
2
Cleared 510(K)
K
16
2782
iHelmet Hair Growth System
2
Cleared 510(K)
K
16
2071
IllumiFlow Laser Cap
2
Cleared 510(K)
K
16
3170
Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
2
Cleared 510(K)
K
16
2994
Capillus302, Capillus312, Capillus352
2
Cleared 510(K)
K
16
1875
LaserCap300, LaserCap224, LaserCap120, LaserCap80
2
Cleared 510(K)
K
16
0728
NutraStim Hair Laser Helmet
2
Cleared 510(K)
K
16
1046
Laser Helmet LH40-EVO
2
Cleared 510(K)
K
16
0285
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
2
Cleared 510(K)
K
15
2587
DermaScalp Laser Cap
2
Cleared 510(K)
K
15
3618
Capillus202
2
Cleared 510(K)
K
15
1662
iRestore
2
Cleared 510(K)
K
15
2019
HairMD
2
Cleared 510(K)
K
15
1516
Capillus82
2
Cleared 510(K)
K
15
0613
LaserCap LC Pro and LC Elite
2
Cleared 510(K)
K
15
0578
Capillus 272 Office Pro
2
Cleared 510(K)
K
14
2824
LX-100 Hair Growth Stimulation System
2
Cleared 510(K)
K
14
3199
Capillus 272 Pro
2
Cleared 510(K)
K
14
1588
NUTRA STIM HAIR LASER COMB
2
Cleared 510(K)
K
14
1596
NUTRA STIM HAIR LASER COMB
2
Cleared 510(K)
K
14
0931
IGROW II HAIR GROWTH SYSTEM
2
Cleared 510(K)
K
14
2573
HairMax LaserComb, HairMax LaserComb
2
Cleared 510(K)
K
14
1567
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM
2
Cleared 510(K)
K
13
2646
SUNETICS CLINICAL BIO-STIMULATION LASER
2
Cleared 510(K)
K
12
1920
LASERBRUSH
2
Cleared 510(K)
K
12
2950
LASER HELMET
2
Cleared 510(K)
K
12
2248
IGROW II HAIR GROWTH SYSTEM
2
Cleared 510(K)
K
11
3097
LASER HELMET
2
Cleared 510(K)
K
11
2524
HAIRMAX LASERCOMB
2
Cleared 510(K)
K
11
1714
HAIRMAX DUAL 12
2
Cleared 510(K)
K
11
0233
HAIRMAX LASERCOMB
2
Cleared 510(K)
K
10
3368
HAIRMAX LASERCOMB
2
Cleared 510(K)
K
09
1496
MEP-90 HAIR GROWTH STIMULATION SYSTEM
2
Cleared 510(K)
K
09
3499
HAIRMAX LASERCOMB
2
Cleared 510(K)
K
06
0305
HAIRMAX LASERCOMB
2
Cleared 510(K)
OZC
Over The Counter Thermal Treatment For Acne.
2
Product Code
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
SU
/
subpart-f—physical-medicine-therapeutic-devices
/
OAP
/
K160728
View Source
NutraStim Hair Laser Helmet
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160728
510(k) Type
Traditional
Applicant
NUTRA LUXE MD LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/16/2016
Days to Decision
184 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
NZY
Light, Lymphedema Reduction, Low Energy
OAP
Laser, Comb, Hair
K
24
2363
HIGHERDOSE Red Light Hat (HG-120K)
K
24
1342
Hair Growth Comb (SZ-23,SZ-23A)
K
24
2620
Breo Laser Hair Growth Comb (Scalp 3L)
K
24
0472
PBM Hair Therapy Cap
K
24
0689
Robin's Egg
K
24
2441
Revian Lyte (10011)
K
24
0456
Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
K
24
0064
Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
K
23
2356
Laser Cap, Model: Hat-01
K
23
1321
Nooance Led And Laser Helmet
K
23
1153
Neuhat Hair Growth System; ibeauty.com Laser Cap
K
22
2790
F65 Laser System
K
23
0134
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
K
23
0597
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
K
22
3862
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
K
23
0336
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
K
22
2477
Hair Growth Device
K
22
2364
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
K
22
2081
ID-510 iRestore Elite
K
21
3789
Intelligence LaserComb
K
21
3027
Laser Hair Growth Comb
K
21
3025
Laser hair growth helmet
K
22
0543
Auxo A300, A150 and APod
K
21
3447
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
K
21
3094
ID-500 iRestore Hair Growth System
K
21
1192
Grivamax Family of Lasers, Models 272 and 148
K
21
1038
Biophotas Celluma RESTORE
K
21
0169
Hair Growth Device
K
20
3826
LaserCap Family of Lasers 300, 224, 120 & 80
K
20
2983
easy Hairfull
K
20
2631
iHelmet Laser Comb
K
19
3008
Tricoglam Home Use
K
20
1854
CAPOGEN Laser Cap
K
20
0464
LG Pra. L Derma LD Scalp Care
K
20
0929
Hair Growth System
K
19
2552
Irradiation Cosmetic Device
K
19
3667
Shapiro MD model laser 272
K
19
2585
Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
K
19
0467
iHelmet Hair Growth System
K
19
2627
Laser Hair Growth Cap
K
19
1754
Hair Growth System
K
19
2425
Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
K
19
2012
Capillus 112, Capillus 244
K
19
1154
Hair Boom 69
K
19
0685
Hair Growth System
K
18
3417
iRestore Professional 282
K
18
3329
Laser Hair Therapy
K
18
2562
Hair Boom 69
K
18
2501
Hair Laser Headband
K
18
1878
Kiierr 272 Laser, Kiierr 148 Laser
K
18
1308
SuperGrow 272, Ultimate 272
K
18
1253
Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
K
18
0885
HairMax Laser
K
18
0617
Hair Up
K
18
0460
Theradome LH40
K
17
3846
DermaScalp Laser Cap
K
17
3729
REVIAN RED
K
17
3678
Diode Laser Cap
K
17
1835
Irradiation Aesthetic Device
K
17
3843
illumiflow 148 Laser Cap
K
17
1775
Theradome LH80 PRO
K
17
2968
Hair Up
K
17
2982
SuperGrow 272, Ultimate 272
K
17
1895
Grivamax Hair Growth System
K
16
2782
iHelmet Hair Growth System
K
16
2071
IllumiFlow Laser Cap
K
16
3170
Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
K
16
2994
Capillus302, Capillus312, Capillus352
K
16
1875
LaserCap300, LaserCap224, LaserCap120, LaserCap80
K
16
0728
NutraStim Hair Laser Helmet
K
16
1046
Laser Helmet LH40-EVO
K
16
0285
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
K
15
2587
DermaScalp Laser Cap
K
15
3618
Capillus202
K
15
1662
iRestore
K
15
2019
HairMD
K
15
1516
Capillus82
K
15
0613
LaserCap LC Pro and LC Elite
K
15
0578
Capillus 272 Office Pro
K
14
2824
LX-100 Hair Growth Stimulation System
K
14
3199
Capillus 272 Pro
K
14
1588
NUTRA STIM HAIR LASER COMB
K
14
1596
NUTRA STIM HAIR LASER COMB
K
14
0931
IGROW II HAIR GROWTH SYSTEM
K
14
2573
HairMax LaserComb, HairMax LaserComb
K
14
1567
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM
K
13
2646
SUNETICS CLINICAL BIO-STIMULATION LASER
K
12
1920
LASERBRUSH
K
12
2950
LASER HELMET
K
12
2248
IGROW II HAIR GROWTH SYSTEM
K
11
3097
LASER HELMET
K
11
2524
HAIRMAX LASERCOMB
K
11
1714
HAIRMAX DUAL 12
K
11
0233
HAIRMAX LASERCOMB
K
10
3368
HAIRMAX LASERCOMB
K
09
1496
MEP-90 HAIR GROWTH STIMULATION SYSTEM
K
09
3499
HAIRMAX LASERCOMB
K
06
0305
HAIRMAX LASERCOMB
OZC
Over The Counter Thermal Treatment For Acne.
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-f—physical-medicine-therapeutic-devices
/
OAP
/
K160728
View Source
NutraStim Hair Laser Helmet
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160728
510(k) Type
Traditional
Applicant
NUTRA LUXE MD LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/16/2016
Days to Decision
184 days
Submission Type
Summary