|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
hair growth device
|
Dongguan Lescolton Medical Equipment Co., Ltd
|
K222477 |
11/18/2022
|
xtrallux alpha (xa136r-usa), xtrallux super plus (xs276r-usa/xs276l-usa), xtrallux turbo pro (xp316r-usa), xtrallux extreme rx (xr352r-usa)
|
Xtrallux, LLC
|
K222364 |
11/16/2022
|
id-510 irestore elite
|
Freedom Laser Therapy, Inc.
|
K222081 |
10/13/2022
|
intelligence lasercomb
|
Yibin Yingtong Intelligent Technology Co.,Ltd.
|
K213789 |
06/24/2022
|
laser hair growth comb
|
Kam Yuen Plastic Products Ltd
|
K213027 |
05/26/2022
|
laser hair growth helmet
|
Kam Yuen Plastic Products Ltd.
|
K213025 |
05/12/2022
|
auxo a300, a150 and apod
|
Auxo Hair, LLC
|
K220543 |
04/20/2022
|
lllt laser hair growth cap, model: hair care 88, hair care 135, hair care 210.
|
Shenzhen CosBeauty Technology Co., Ltd.
|
K213447 |
01/19/2022
|
id-500 irestore hair growth system
|
Freedom Laser Therapy, Inc.
|
K213094 |
12/22/2021
|
grivamax family of lasers, models 272 and 148
|
Leana Orders, Inc
|
K211192 |
07/20/2021
|
biophotas celluma restore
|
Biophotas INC
|
K211038 |
06/29/2021
|
hair growth device
|
Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd
|
K210169 |
04/16/2021
|
lasercap family of lasers 300, 224, 120 & 80
|
Transdermal Cap, Inc.
|
K203826 |
03/29/2021
|
ihelmet laser comb
|
Slinph Technologies Co., Ltd
|
K202631 |
12/08/2020
|
easy hairfull
|
Y&J BIO Co., Ltd.
|
K202983 |
12/08/2020
|
tricoglam home use
|
Advihair S.R.L.
|
K193008 |
12/03/2020
|
capogen laser cap
|
Nature Incredible Inc
|
K201854 |
09/01/2020
|
lg pra. l derma ld scalp care
|
LG Electronics, Inc.
|
K200464 |
07/23/2020
|
hair growth system
|
Xuzhou Kernel Medical Equipment Co., Ltd.
|
K200929 |
06/03/2020
|
irradiation cosmetic device
|
Chongqing Peninsula Medical Technology Co., Ltd.
|
K192552 |
04/17/2020
|
shapiro md model laser 272
|
Conversion Labs, PR, LLC
|
K193667 |
03/25/2020
|
bosley revitalizer 96 laser cap, bosley revitalizer 96 xl laser cap
|
PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
|
K192585 |
01/29/2020
|
ihelmet hair growth system
|
Slinph Technologies Co., LTD
|
K190467 |
12/26/2019
|
laser hair growth cap
|
Shang Fa Biotechnology Co.
|
K192627 |
12/13/2019
|
hair growth system
|
Kunshan Bella Optical technology Co., Ltd.
|
K191754 |
11/22/2019
|
hair boom 69, hair boom air, ulike hair upup
|
Won Tech Co., Ltd.
|
K192425 |
09/30/2019
|
capillus 112, capillus 244
|
Capillus
|
K192012 |
09/12/2019
|
hair boom 69
|
Wontech
|
K191154 |
07/29/2019
|
hair growth system
|
Xuzhou Kernel Medical Equipment Co., Ltd.
|
K190685 |
07/26/2019
|
irestore professional 282
|
Freedom Laser Therapy, Inc.
|
K183417 |
05/17/2019
|
laser hair therapy
|
OMM Imports, Inc. D/B/A Zero Gravity
|
K183329 |
01/16/2019
|
hair boom 69
|
WonTech
|
K182562 |
11/16/2018
|
hair laser headband
|
Pulsaderm LLC
|
K182501 |
10/26/2018
|
kiierr 272 laser, kiierr 148 laser
|
Kiierr International, LLC
|
K181878 |
09/05/2018
|
supergrow 272, ultimate 272
|
Super Grow Lasers
|
K181308 |
08/15/2018
|
bosley revitalizer 272 laser cap, bosley revitalizer 164 laser cup
|
PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
|
K181253 |
08/10/2018
|
hairmax laser
|
Lexington International, LLC
|
K180885 |
06/20/2018
|
hair up
|
Y&J BIO Co, Ltd.,
|
K180617 |
06/01/2018
|
theradome lh40
|
Theradome, Inc.
|
K180460 |
05/18/2018
|
dermascalp laser cap
|
DermaScalp LLC
|
K173846 |
03/21/2018
|
diode laser cap
|
Cosmo Far East Technology Limited
|
K173678 |
02/28/2018
|
revian red
|
PhotonMD, Inc
|
K173729 |
02/28/2018
|
irradiation aesthetic device
|
Chongqing Peninsula Medical Technology Co., Ltd.
|
K171835 |
01/30/2018
|
illumiflow 148 laser cap
|
EGlobal, LLC
|
K173843 |
01/26/2018
|
theradome lh80 pro
|
Theradome Inc.
|
K171775 |
01/09/2018
|
hair up
|
Y&J BIO Co., Ltd.
|
K172968 |
01/05/2018
|
supergrow 272, ultimate 272
|
Super Grow Lasers
|
K172982 |
12/19/2017
|
grivamax hair growth system
|
Leana Orders, Inc.
|
K171895 |
08/22/2017
|
ihelmet hair growth system
|
Slinph Technologies Co., LTD
|
K162782 |
04/04/2017
|
illumiflow laser cap
|
EGLOBAL, LLC
|
K162071 |
02/24/2017
|
capillus 82, capillus 202, capillus 272 pro, 272 office pro, capillus 302, capillus 312, and capillus 352
|
CAPILLUS, LLC
|
K163170 |
01/31/2017
|
capillus302, capillus312, capillus352
|
CAPILLUS, LLC
|
K162994 |
11/18/2016
|
lasercap300, lasercap224, lasercap120, lasercap80
|
TRANSDERMAL CAP, INC.
|
K161875 |
09/30/2016
|
nutrastim hair laser helmet
|
NUTRA LUXE MD LLC
|
K160728 |
09/16/2016
|
laser helmet lh40-evo
|
Theradome, Inc
|
K161046 |
05/12/2016
|
capillus272 pro, capillus272 officepro, capillus82, capillus202
|
CAPILLUS, LLC
|
K160285 |
04/25/2016
|
dermascalp laser cap
|
DERMASCALP LLC
|
K152587 |
02/04/2016
|
irestore
|
Freedom Laser Therapy, Inc.
|
K151662 |
01/06/2016
|
hairmd
|
TROPHY SKIN, INC.
|
K152019 |
11/16/2015
|
capillus82
|
Capillus, LLC
|
K151516 |
08/21/2015
|
lasercap lc pro and lc elite
|
TRANSDERMAL CAP, INC.
|
K150613 |
07/22/2015
|
capillus 272 office pro
|
Capillus, LLC
|
K150578 |
06/09/2015
|
lx-100 hair growth stimulation system
|
Hairlabs International Inc
|
K142824 |
04/14/2015
|
capillus 272 pro
|
Capillus, LLC
|
K143199 |
01/29/2015
|
nutra stim hair laser comb
|
NUTRA LUXE MD, LLC
|
K141588 |
01/08/2015
|
nutra stim hair laser comb
|
NUTRA LUXE MD, LLC
|
K141596 |
01/08/2015
|
igrow ii hair growth system
|
APIRA SCIENCE, INC.
|
K140931 |
12/05/2014
|
hairmax lasercomb, hairmax lasercomb
|
LEXINGTON INTERNATIONAL, LLC
|
K142573 |
12/01/2014
|
igrow - ii hair growth system, igrow hair growth system
|
APIRA SCIENCE, INC.
|
K141567 |
08/21/2014
|
sunetics clinical bio-stimulation laser
|
SUNETICS INTERNATIONAL MARKETING GROUP, LLC
|
K132646 |
12/20/2013
|
laserbrush
|
SUNETICS INTERNATIONAL MARKETING GROUP, LLC
|
K121920 |
06/27/2013
|
laser helmet
|
THERADOME INC.
|
K122950 |
06/14/2013
|
igrow ii hair growth system
|
APIRA SCIENCE, INC.
|
K122248 |
12/05/2012
|
laser helmet
|
THERADOME INC.
|
K113097 |
03/02/2012
|
hairmax lasercomb
|
LEXINGTON INTERNATIONAL, LLC
|
K112524 |
09/26/2011
|
hairmax dual 12
|
LEXINGTON INTERNATIONAL, LLC
|
K111714 |
08/16/2011
|
hairmax lasercomb
|
LEXINGTON INTERNATIONAL, LLC
|
K110233 |
05/27/2011
|
hairmax lasercomb
|
LEXINGTON INTERNATIONAL, LLC
|
K103368 |
04/06/2011
|
e-light line
|
ESPANSIONE MARKETING S.P.A
|
K092734 |
09/20/2010
|
mep-90 hair growth stimulation system
|
MIDWEST R.F. LLC.
|
K091496 |
02/23/2010
|
hairmax lasercomb
|
LEXINGTON INTERNATIONAL, LLC
|
K093499 |
11/23/2009
|
hairmax lasercomb
|
LEXINGTON INTERNATIONAL, LLC
|
K060305 |
01/18/2007
|