FDA 510(k) Applications for Medical Device Product Code "ONF"
(Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
