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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 94 of 94 Results
ProductCode: onf Decision Date To: 09/10/2022
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ipl hair removal device Shenzhen Noble Smart Manufacturing Tech Co. Ltd K222598 11/17/2022
10pl Tentech Co. Ltd. K220794 11/10/2022
hand-held ipl device (ipl home use hair removal device) model:fz-608, fz-608g, fz-100, fz-200 Shenzhen IONKA Medical Technology Co., Ltd. K221214 09/21/2022
diamond air+ (ui04a, ui04b, ui04c) Ulike Co., Ltd K221553 09/15/2022
xlase plus Biotec Italia, SRL K212790 08/15/2022
intense pulsed light equipment Beijing Globalipl Development Co., Ltd. K220385 08/12/2022
inmode multi-system InMode Ltd. K221571 06/30/2022
intense pulsed light (ipl) system, model: t013c, t015c, t015k Shenzhen Fansizhe Science And Technology Co., Ltd K221569 06/30/2022
intense pulsed light (ipl) system Shenzhen Fansizhe Science And Technology Co., Ltd K212881 04/11/2022
ipl hair removal device Ulike Co., Ltd K213558 03/08/2022
aimanfun lumea comfort, a-2789/a-3588 Kam Yuen Plastic Products Ltd. K212907 12/02/2021
ipl hair remover, model: g993, g996, g998 and g885 Shenzhen Mywin Technology Co., Ltd. K211368 10/04/2021
red wave hair removal Shenzhen Accompany Technology Co., Ltd. K212099 09/24/2021
ipl hair removal device (model: kca423) Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd K210119 05/21/2021
e>eyec E-SWIN K200616 06/11/2020
photodynamic therapy (pdt) equipment Shangdong Huamei Technology Co., Ltd. K200751 05/21/2020
ipl treatment systems Shanghai Apolo Medical Technology Co., Ltd. K200746 05/15/2020
mt one M&T SRL K192856 04/24/2020
ipl + diode laser machine Beijing Globalipl Development Co., Ltd. K193328 03/25/2020
lucent : ipl LUVO Medical Technologies, Inc. K193072 03/05/2020
stellar m22 for intense pulsed light (ipl) and laser system Lumenis Ltd. K193500 01/16/2020
deka luxea El..EN. Electronic Engineering SPA K192539 12/16/2019
intense pulsed light treatment system Shangdong Huamei Technology Co., Ltd. K192521 12/06/2019
multi-modality workstation Beijing Superlaser Technology Co., Ltd. K192519 11/27/2019
mt one diamond M&T Srl K191942 10/17/2019
sensilight pro / pistol ipl EL Global Trade Ltd. K183260 03/18/2019
vydence laser family Vydence Medical Industria E Comercio Ltda K190007 03/01/2019
ipl hair removal device Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. K183217 02/15/2019
magma spark pro (magma spark plus, alpha) Formatk Systems Ltd. K183307 12/11/2018
shiny rpl system IDS, Ltd. K181868 10/05/2018
beurer ipl 8500 device/ ipl velvetskin pro Home Well Trading LTD K181734 09/19/2018
ipl hair removal device joy version Shen Zhen CosBeauty Co., Ltd K173813 09/07/2018
beurer ipl 5500 device/ ipl 5000/ ipl pureskin pro Home Well Trading LTD K181121 06/28/2018
harmony xl multi-application platform Alma Lasers Inc. K181298 06/13/2018
etherea mx Vydence Medical Industria E Comercio Ltda K171443 04/20/2018
lumilisse ipl hair remover Conair Corporation K172791 01/18/2018
micro ipl EL Global Trade Ltd K172181 10/13/2017
mt one M&T S.R.L K172413 10/06/2017
silk'n infinity Home Skinovations Ltd. K171433 08/11/2017
m22 and resurfx systems LUMENIS, LTD. K170060 08/09/2017
duo STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD K161565 09/01/2016
ipl therapy machine BEIJING ADSS DEVELOPMENT CO., LTD K161286 08/04/2016
forma system, forma light system FORMATK SYSTEMS LTD. K160195 04/15/2016
superbium BIOS S.R.L K153229 04/12/2016
magma system FORMATK SYSTEMS LTD. K153566 04/06/2016
venus versa system Venus Concept Ltd. K153717 03/21/2016
venus versa system VENUS CONCEPT LTD. K152790 01/20/2016
quanta forte QUANTA SYSTEM SPA K152714 12/21/2015
ellipse nordlys/ellipse nordlys+, ellipse sirius, ellipse infinity, ellipse mjolner, ellipse nordlys ultra Ellipse A/S K150907 07/07/2015
ipulse smooth skin gold hair removal system Ipulse Limited K143003 06/18/2015
shaser skin beauty intense pulsed light system family for acne SHASER, INC. K150282 05/27/2015
exilite BTL Industries, Inc. K150051 04/08/2015
harmony lite ALMA INC. K141237 03/13/2015
lumenis m22 system Lumenis Ltd. K142860 01/21/2015
mini me ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) K143339 12/19/2014
platinumgmt ipl system cloud GLOBAL MEDICAL TECHNOLOGY S.L. K140668 12/19/2014
glide device HOME SKINOVATIONS LTD. K141242 10/17/2014
ellipse i2pl+/ellipse multiflex+ ELLIPSE A/S K140670 09/25/2014
shaser skin beauty intense pulsed light system family SHASER, INC. K141583 07/22/2014
a-tone ipl system YBK INVESTMENT INC. K131712 05/30/2014
lumena fh hair removal system SHASER, INC. K140631 05/16/2014
shaser v-mini 2 hair removal system SHASER, INC. K133201 02/12/2014
me SYNERON BEAUTY LTD. K131649 12/11/2013
shaser v-mini rx SHASER, INC. K132170 11/26/2013
multifunctional series BEIJING HONKON TECHNOLOGIES CO., LTD K131859 10/18/2013
shaser hrs2 rx hair removal system SHASER, INC. K132266 09/30/2013
shaser v-mini hair removal system SHASER, INC. K130015 06/13/2013
inmode sr ipl device INMODE MD LTD. K123860 04/02/2013
acleara, theraclear THERAVANT CORPORATION K123889 03/04/2013
ipl therapy system BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD K123435 02/11/2013
intense pulsed light (ipl) systems BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. K122995 01/22/2013
me SYNERON BEAUTY LTD. K123845 01/10/2013
me hair2go SYNERON MEDICAL LTD. K121598 10/12/2012
isolaz 2 intense pulsed light system SOLTA MEDICAL, INC. K121515 06/05/2012
shaser hrs2 hair removal system SHASER, INC. K120080 05/25/2012
etherea REGULATORY INSIGHT, INC. K112505 04/06/2012
medicam evolux, evostar, evolight and evolase pulsed light system MEDICAM INC. K111350 09/29/2011
shaser ipl hair removal system SHASER, INC. K103560 05/18/2011
joule multi-platform system SCITON, INC. K101916 03/18/2011
ipl therapy system BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT K101901 03/08/2011
deka synchro ft EL.EN. ELECTRONIC ENGINEERING SPA K103288 01/31/2011
ipulselight ipl system, models hs 300c and hs 650 SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD. K093627 01/18/2011
ahwon's ipl system AHWON MEDI INSTRUMENT CO., LTD K102857 01/14/2011
mediflash and esteflash DERMEO K093168 05/21/2010
mattioli pulse two/three plus family MATTIOLI ENGINEERING CORP. K100053 03/10/2010
smoothcool JEISYS MEDICAL, INC. K092326 03/05/2010
fusion system ECLIPSEMED GLOBAL, INC K093465 01/05/2010
gsd intense pulsed light system, models: gp666c4, gp666c SHENZHEN GSD TECH. CO., LTD. K091664 11/16/2009
or-light YPERION TECHNOLOGY K090724 10/07/2009
leda QUANTEL DERMA GMBH K090762 08/28/2009
minisilk ft EL.EN. ELECTRONIC ENGINEERING SPA K082040 08/27/2009
stratapulse ts and stratapulse ADVANCED MEDICAL PHOTONICS K090837 06/17/2009
trios system VIORA LTD. K090399 06/10/2009
accelawave system GENESIS BIOSYSTEMS, INC. K082484 09/12/2008
 
 
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