FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K090837 |
ADVANCED MEDICAL PHOTONICS |
STRATAPULSE TS AND STRATAPULSE |
06/17/2009 |
K102857 |
AHWON MEDI INSTRUMENT CO., LTD |
AHWON'S IPL SYSTEM |
01/14/2011 |
K141237 |
ALMA INC. |
HARMONY LITE |
03/13/2015 |
K181298 |
Alma Lasers Inc. |
Harmony XL Multi-Application Platform |
06/13/2018 |
K161286 |
BEIJING ADSS DEVELOPMENT CO., LTD |
IPL Therapy Machine |
08/04/2016 |
K220385 |
Beijing Globalipl Development Co., Ltd. |
Intense Pulsed Light Equipment |
08/12/2022 |
K193328 |
Beijing Globalipl Development Co., Ltd. |
IPL + Diode Laser Machine |
03/25/2020 |
K131859 |
BEIJING HONKON TECHNOLOGIES CO., LTD |
MULTIFUNCTIONAL SERIES |
10/18/2013 |
K122995 |
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. |
INTENSE PULSED LIGHT (IPL) SYSTEMS |
01/22/2013 |
K123435 |
BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD |
IPL THERAPY SYSTEM |
02/11/2013 |
K101901 |
BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT |
IPL THERAPY SYSTEM |
03/08/2011 |
K192519 |
Beijing Superlaser Technology Co., Ltd. |
Multi-modality workstation |
11/27/2019 |
K150051 |
BTL Industries, Inc. |
Exilite |
04/08/2015 |
K093168 |
DERMEO |
MEDIFLASH AND ESTEFLASH |
05/21/2010 |
K200616 |
E-SWIN |
E>EyeC |
06/11/2020 |
K093465 |
ECLIPSEMED GLOBAL, INC |
FUSION SYSTEM |
01/05/2010 |
K082040 |
EL.EN. ELECTRONIC ENGINEERING SPA |
MINISILK FT |
08/27/2009 |
K140670 |
ELLIPSE A/S |
ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ |
09/25/2014 |
K160195 |
FORMATK SYSTEMS LTD. |
Forma System, Forma Light System |
04/15/2016 |
K082484 |
GENESIS BIOSYSTEMS, INC. |
ACCELAWAVE SYSTEM |
09/12/2008 |
K140668 |
GLOBAL MEDICAL TECHNOLOGY S.L. |
PLATINUMGMT IPL SYSTEM CLOUD |
12/19/2014 |
K181868 |
IDS, Ltd. |
SHINY RPL System |
10/05/2018 |
K143339 |
ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) |
Mini me |
12/19/2014 |
K123860 |
INMODE MD LTD. |
INMODE SR IPL DEVICE |
04/02/2013 |
K092326 |
JEISYS MEDICAL, INC. |
SMOOTHCOOL |
03/05/2010 |
K212907 |
Kam Yuen Plastic Products Ltd. |
Aimanfun Lumea Comfort, A-2789/A-3588 |
12/02/2021 |
K193072 |
LUVO Medical Technologies, Inc. |
Lucent : IPL |
03/05/2020 |
K100053 |
MATTIOLI ENGINEERING CORP. |
MATTIOLI PULSE TWO/THREE PLUS FAMILY |
03/10/2010 |
K111350 |
MEDICAM INC. |
MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM |
09/29/2011 |
K192521 |
Shangdong Huamei Technology Co., Ltd. |
Intense Pulsed Light Treatment System |
12/06/2019 |
K230816 |
Shangdong Huamei Technology Co., Ltd. |
Intense Pulsed Light Treatment System |
04/21/2023 |
K093627 |
SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD. |
IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 |
01/18/2011 |
K200746 |
Shanghai Apolo Medical Technology Co., Ltd. |
IPL Treatment Systems |
05/15/2020 |
K220214 |
Shanghai Omni Laser Skinology Co., Ltd. |
Painless IPL System - KDT750 |
02/18/2023 |
K140631 |
SHASER, INC. |
LUMENA FH HAIR REMOVAL SYSTEM |
05/16/2014 |
K120080 |
SHASER, INC. |
SHASER HRS2 HAIR REMOVAL SYSTEM |
05/25/2012 |
K132266 |
SHASER, INC. |
SHASER HRS2 RX HAIR REMOVAL SYSTEM |
09/30/2013 |
K103560 |
SHASER, INC. |
SHASER IPL HAIR REMOVAL SYSTEM |
05/18/2011 |
K141583 |
SHASER, INC. |
SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY |
07/22/2014 |
K150282 |
SHASER, INC. |
Shaser Skin Beauty Intense Pulsed Light System Family for Acne |
05/27/2015 |
K133201 |
SHASER, INC. |
SHASER V-MINI 2 HAIR REMOVAL SYSTEM |
02/12/2014 |
K130015 |
SHASER, INC. |
SHASER V-MINI HAIR REMOVAL SYSTEM |
06/13/2013 |
K132170 |
SHASER, INC. |
SHASER V-MINI RX |
11/26/2013 |
K212099 |
Shenzhen Accompany Technology Co., Ltd. |
Red Wave Hair Removal |
09/24/2021 |
K210119 |
Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd |
IPL Hair Removal Device (Model: KCA423) |
05/21/2021 |
K091664 |
SHENZHEN GSD TECH. CO., LTD. |
GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C |
11/16/2009 |
K221214 |
Shenzhen IONKA Medical Technology Co., Ltd. |
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 |
09/21/2022 |
K211368 |
Shenzhen Mywin Technology Co., Ltd. |
IPL Hair Remover, Model: G993, G996, G998 and G885 |
10/04/2021 |
K231394 |
Smedtrum Medical Technology Co., Ltd. |
Intense Pulsed Light System |
08/09/2023 |
K121515 |
SOLTA MEDICAL, INC. |
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM |
06/05/2012 |
K161565 |
STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD |
DUO |
09/01/2016 |
K123845 |
SYNERON BEAUTY LTD. |
ME |
01/10/2013 |
K131649 |
SYNERON BEAUTY LTD. |
ME |
12/11/2013 |
K121598 |
SYNERON MEDICAL LTD. |
ME HAIR2GO |
10/12/2012 |
K220794 |
Tentech Co. Ltd. |
10PL |
11/10/2022 |
K123889 |
THERAVANT CORPORATION |
ACLEARA, THERACLEAR |
03/04/2013 |
K213558 |
Ulike Co., Ltd |
IPL Hair Removal Device |
03/08/2022 |
K232192 |
Venus Concept Inc. |
Venus Versa PRO System |
09/11/2023 |
K152790 |
VENUS CONCEPT LTD. |
Venus Versa System |
01/20/2016 |
K153717 |
Venus Concept Ltd. |
Venus Versa System |
03/21/2016 |
K090399 |
VIORA LTD. |
TRIOS SYSTEM |
06/10/2009 |
K131712 |
YBK INVESTMENT INC. |
A-TONE IPL SYSTEM |
05/30/2014 |
K090724 |
YPERION TECHNOLOGY |
OR-LIGHT |
10/07/2009 |