FDA Product Code
FDA Product Code ONF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 74 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261204 | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 | Traditional | PDF ↗ |
| K251545 | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025-09-04 | Traditional | PDF ↗ |
| K231952 | MEDILIGHT | Medicreations, LLC | 2025-09-03 | Special | PDF ↗ |
| K243123 | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025-07-03 | Traditional | PDF ↗ |
| K250281 | DEKA LOTUS | El.En S.P.A. | 2025-02-26 | Special | PDF ↗ |
| K242440 | Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. | 2024-11-14 | Traditional | PDF ↗ |
| K240314 | MULA (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | 2024-08-21 | Traditional | PDF ↗ |
| K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 | Traditional | PDF ↗ |
| K233473 | DEKA LOTUS | El.En S.P.A. | 2024-05-16 | Traditional | PDF ↗ |
| K233307 | Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. | 2024-03-15 | Traditional | PDF ↗ |
| K232708 | Intense pulsed light therapy device | Hebei Zhemai Technology Co., Ltd. | 2023-12-01 | Traditional | PDF ↗ |
| K232192 | Venus Versa PRO System | Venus Concept, Inc. | 2023-09-11 | Special | PDF ↗ |
| K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 | Traditional | PDF ↗ |
| K230816 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2023-04-21 | Special | PDF ↗ |
| K220214 | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | 2023-02-18 | Traditional | PDF ↗ |
| K220794 | 10PL | Tentech Co. , Ltd. | 2022-11-10 | Traditional | PDF ↗ |
| K221214 | 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. | 2022-09-21 | Traditional | PDF ↗ |
| K220385 | Intense Pulsed Light Equipment | Beijing Globalipl Development Co., Ltd. | 2022-08-12 | Traditional | PDF ↗ |
| K213558 | IPL Hair Removal Device | Ulike Co., Ltd. | 2022-03-08 | Traditional | PDF ↗ |
| K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products , Ltd. | 2021-12-02 | Special | PDF ↗ |
| K211368 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | 2021-10-04 | Traditional | PDF ↗ |
| K212099 | Red Wave Hair Removal | Shenzhen Accompany Technology Co., Ltd. | 2021-09-24 | Traditional | PDF ↗ |
| K210119 | IPL Hair Removal Device (Model: KCA423) | Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. | 2021-05-21 | Traditional | PDF ↗ |
| K200616 | E>EyeC | E-Swin | 2020-06-11 | Traditional | PDF ↗ |
| K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-15 | Traditional | PDF ↗ |
| K193328 | IPL + Diode Laser Machine | Beijing Globalipl Development Co., Ltd. | 2020-03-25 | Traditional | PDF ↗ |
| K193072 | Lucent : IPL | Luvo Medical Technologies, Inc. | 2020-03-05 | Traditional | PDF ↗ |
| K192521 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2019-12-06 | Traditional | PDF ↗ |
| K192519 | Multi-modality workstation | Beijing Superlaser Technology Co., Ltd. | 2019-11-27 | Traditional | PDF ↗ |
| K181868 | SHINY RPL System | Ids, Ltd. | 2018-10-05 | Traditional | PDF ↗ |
| K181298 | Harmony XL Multi-Application Platform | Alma Lasers, Inc. | 2018-06-13 | Special | PDF ↗ |
| K161565 | DUO | Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd | 2016-09-01 | Traditional | PDF ↗ |
| K161286 | IPL Therapy Machine | Beijing Adss Development Co., Ltd. | 2016-08-04 | Traditional | PDF ↗ |
| K160195 | Forma System, Forma Light System | Formatk Systems , Ltd. | 2016-04-15 | Traditional | PDF ↗ |
| K153717 | Venus Versa System | Venus Concept , Ltd. | 2016-03-21 | Traditional | PDF ↗ |
| K152790 | Venus Versa System | Venus Concept , Ltd. | 2016-01-20 | Traditional | PDF ↗ |
| K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | Shaser, Inc. | 2015-05-27 | Traditional | PDF ↗ |
| K150051 | Exilite | BTL Industries, Inc. | 2015-04-08 | Traditional | PDF ↗ |
| K141237 | HARMONY LITE | Alma, Inc. | 2015-03-13 | Traditional | PDF ↗ |
| K140668 | PLATINUMGMT IPL SYSTEM CLOUD | Global Medical Technology S.L. | 2014-12-19 | Traditional | PDF ↗ |
| K143339 | Mini me | Iluminage Ltd.(Formerly Syneron Beauty Ltd.) | 2014-12-19 | Special | PDF ↗ |
| K140670 | ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ | Ellipse A/S | 2014-09-25 | Traditional | PDF ↗ |
| K141583 | SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY | Shaser, Inc. | 2014-07-22 | Special | PDF ↗ |
| K131712 | A-TONE IPL SYSTEM | Ybk Investment, Inc. | 2014-05-30 | Traditional | PDF ↗ |
| K140631 | LUMENA FH HAIR REMOVAL SYSTEM | Shaser, Inc. | 2014-05-16 | Special | PDF ↗ |
| K133201 | SHASER V-MINI 2 HAIR REMOVAL SYSTEM | Shaser, Inc. | 2014-02-12 | Traditional | PDF ↗ |
| K131649 | ME | Syneron Beauty , Ltd. | 2013-12-11 | Traditional | PDF ↗ |
| K132170 | SHASER V-MINI RX | Shaser, Inc. | 2013-11-26 | Traditional | PDF ↗ |
| K131859 | MULTIFUNCTIONAL SERIES | Beijing Honkon Technologies Co., Ltd. | 2013-10-18 | Traditional | PDF ↗ |
| K132266 | SHASER HRS2 RX HAIR REMOVAL SYSTEM | Shaser, Inc. | 2013-09-30 | Traditional | PDF ↗ |
| K130015 | SHASER V-MINI HAIR REMOVAL SYSTEM | Shaser, Inc. | 2013-06-13 | Traditional | PDF ↗ |
| K123860 | INMODE SR IPL DEVICE | Inmode MD , Ltd. | 2013-04-02 | Traditional | PDF ↗ |
| K123889 | ACLEARA, THERACLEAR | Theravant Corporation | 2013-03-04 | Traditional | PDF ↗ |
| K123435 | IPL THERAPY SYSTEM | Beijing Sincoheren S&T Development Co, Ltd. | 2013-02-11 | Traditional | PDF ↗ |
| K122995 | INTENSE PULSED LIGHT (IPL) SYSTEMS | Beijing Kes Biology Technology Co., Ltd. | 2013-01-22 | Traditional | PDF ↗ |
| K123845 | ME | Syneron Beauty , Ltd. | 2013-01-10 | Special | PDF ↗ |
| K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012-10-12 | Traditional | PDF ↗ |
| K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM | Solta Medical, Inc. | 2012-06-05 | Special | PDF ↗ |
| K120080 | SHASER HRS2 HAIR REMOVAL SYSTEM | Shaser, Inc. | 2012-05-25 | Traditional | PDF ↗ |
| K111350 | MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM | Medicam, Inc. | 2011-09-29 | Traditional | PDF ↗ |
| K103560 | SHASER IPL HAIR REMOVAL SYSTEM | Shaser, Inc. | 2011-05-18 | Traditional | PDF ↗ |
| K101901 | IPL THERAPY SYSTEM | Beijing Starlight Science & Technology Development | 2011-03-08 | Traditional | PDF ↗ |
| K093627 | IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 | Shanghai Apolo Medical Technologies Co., Ltd. | 2011-01-18 | Traditional | PDF ↗ |
| K102857 | AHWON'S IPL SYSTEM | Ahwon Medi Instrument Co., Ltd. | 2011-01-14 | Traditional | PDF ↗ |
| K093168 | MEDIFLASH AND ESTEFLASH | Dermeo | 2010-05-21 | Traditional | PDF ↗ |
| K100053 | MATTIOLI PULSE TWO/THREE PLUS FAMILY | Mattioli Engineering Corp. | 2010-03-10 | Traditional | PDF ↗ |
| K092326 | SMOOTHCOOL | Jeisys Medical, Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K093465 | FUSION SYSTEM | Eclipsemed Global, Inc. | 2010-01-05 | Traditional | PDF ↗ |
| K091664 | GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009-11-16 | Traditional | PDF ↗ |
| K090724 | OR-LIGHT | Yperion Technology | 2009-10-07 | Traditional | PDF ↗ |
| K082040 | MINISILK FT | El.En Electronic Engineering Spa | 2009-08-27 | Traditional | PDF ↗ |
| K090837 | STRATAPULSE TS AND STRATAPULSE | Advanced Medical Photonics | 2009-06-17 | Traditional | PDF ↗ |
| K090399 | TRIOS SYSTEM | Viora , Ltd. | 2009-06-10 | Traditional | PDF ↗ |
| K082484 | ACCELAWAVE SYSTEM | Genesis Biosystems, Inc. | 2008-09-12 | Traditional | PDF ↗ |
Product code ONF · Class II · General, Plastic Surgery. Data: openFDA.