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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 71 of 71 Results
ProductCode: OAP Decision Date To: 05/21/2021
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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
easy hairfull Y&J BIO Co., Ltd. K202983 12/08/2020
ihelmet laser comb Slinph Technologies Co., Ltd K202631 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
 
 
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