Panels › General, Plastic Surgery › Product code ONF · Class 2
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Regulation 878.4810
1510(k)s in 12 months (74 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ONF
| Company | 510(k)s | Recalls |
|---|---|---|
| Shaser, Inc. | 9 | 0 |
| Venus Concept , Ltd. | 3 | 0 |
| Beijing Adss Development Co., Ltd. | 2 | 0 |
| Beijing Globalipl Development Co., Ltd. | 2 | 0 |
| El.En S.P.A. | 2 | 0 |
| Shangdong Huamei Technology Co., Ltd. | 2 | 0 |
| Smedtrum Medical Technology Co., Ltd. | 2 | 0 |
| Syneron Beauty , Ltd. | 2 | 0 |
| Advanced Medical Photonics | 1 | 0 |
| Ahwon Medi Instrument Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2026 | K261204 | Intense Pulsed Light Therapy Device Sanhe LEFIS Electronics Co., Ltd., CN | ONF |
| Sep 4, 2025 | K251545 | Intense Pulsed Light Therapy Device (MMABM-1) Micowey Medical Equipment (Guangxi) Co., Ltd., CN | ONF |
| Sep 3, 2025 | K231952 | MEDILIGHT Medicreations, LLC | ONF |
| Jul 3, 2025 | K243123 | IPL Treatment Device (MDSQMC-01) Medusa (Guangxi)Medical Devices Co., Ltd., CN | ONF |
| Feb 26, 2025 | K250281 | DEKA LOTUS El.En S.P.A., IT | ONF |
| Nov 14, 2024 | K242440 | Intense Pulsed Light Treatment System (LK-PT) Nanjing Bestview Laser S&T Co., Ltd., CN | ONF |
| Aug 21, 2024 | K240314 | MULA (K2-A1) Guangzhou Ciellulu Photoelectric Technology Co., Ltd., CN | ONF |
| May 17, 2024 | K240482 | Intense Pulsed Light System (ST-690) Smedtrum Medical Technology Co., Ltd., TW | ONF |
| May 16, 2024 | K233473 | DEKA LOTUS El.En S.P.A., IT | ONF |
| Mar 15, 2024 | K233307 | Intensity Pulsed Light Therapy System Beijing Adss Development Co., Ltd., CN | ONF |
| Dec 1, 2023 | K232708 | Intense pulsed light therapy device Hebei Zhemai Technology Co., Ltd., CN | ONF |
| Sep 11, 2023 | K232192 | Venus Versa PRO System Venus Concept, Inc. | ONF |
| Aug 9, 2023 | K231394 | Intense Pulsed Light System Smedtrum Medical Technology Co., Ltd., TW | ONF |
| Apr 21, 2023 | K230816 | Intense Pulsed Light Treatment System Shangdong Huamei Technology Co., Ltd., CN | ONF |
| Feb 18, 2023 | K220214 | Painless IPL System - KDT750 Shanghai Omni Laser Skinology Co., Ltd., CN | ONF |
| Nov 10, 2022 | K220794 | 10PL Tentech Co. , Ltd., KR | ONF |
| Sep 21, 2022 | 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., CN | ONF |
| Aug 12, 2022 | K220385 | Intense Pulsed Light Equipment Beijing Globalipl Development Co., Ltd., CN | ONF |
| Mar 8, 2022 | K213558 | IPL Hair Removal Device Ulike Co., Ltd., KR | ONF |
| Dec 2, 2021 | K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 Kam Yuen Plastic Products , Ltd., CN | ONF |
| Oct 4, 2021 | K211368 | IPL Hair Remover, Model: G993, G996, G998 and G885 Shenzhen Mywin Technology Co., Ltd., CN | ONF |
| Sep 24, 2021 | K212099 | Red Wave Hair Removal Shenzhen Accompany Technology Co., Ltd., CN | ONF |
| May 21, 2021 | K210119 | IPL Hair Removal Device (Model: KCA423) Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd., CN | ONF |
| Jun 11, 2020 | K200616 | E>EyeC E-Swin, FR | ONF |
| May 15, 2020 | K200746 | IPL Treatment Systems Shanghai Apolo Medical Technology Co., Ltd., CN | ONF |
| Mar 25, 2020 | K193328 | IPL + Diode Laser Machine Beijing Globalipl Development Co., Ltd., CN | ONF |
| Mar 5, 2020 | K193072 | Lucent : IPL Luvo Medical Technologies, Inc., CA | ONF |
| Dec 6, 2019 | K192521 | Intense Pulsed Light Treatment System Shangdong Huamei Technology Co., Ltd., CN | ONF |
| Nov 27, 2019 | K192519 | Multi-modality workstation Beijing Superlaser Technology Co., Ltd., CN | ONF |
| Oct 5, 2018 | K181868 | SHINY RPL System Ids, Ltd., KR | ONF |
| Jun 13, 2018 | K181298 | Harmony XL Multi-Application Platform Alma Lasers, Inc. | ONF |
| Sep 1, 2016 | K161565 | DUO Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd, CN | ONF |
| Aug 4, 2016 | K161286 | IPL Therapy Machine Beijing Adss Development Co., Ltd., CN | ONF |
| Apr 15, 2016 | K160195 | Forma System, Forma Light System Formatk Systems , Ltd., IL | ONF |
| Mar 21, 2016 | K153717 | Venus Versa System Venus Concept , Ltd. | ONF |
| Jan 20, 2016 | K152790 | Venus Versa System Venus Concept , Ltd. | ONF |
| May 27, 2015 | K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne Shaser, Inc. | ONF |
| Apr 8, 2015 | K150051 | Exilite BTL Industries, Inc. | ONF |
| Mar 13, 2015 | K141237 | HARMONY LITE Alma, Inc. | ONF |
| Dec 19, 2014 | K143339 | Mini me Iluminage Ltd.(Formerly Syneron Beauty Ltd.), IL | ONF |
| Dec 19, 2014 | K140668 | PLATINUMGMT IPL SYSTEM CLOUD Global Medical Technology S.L., ES | ONF |
| Sep 25, 2014 | K140670 | ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ Ellipse A/S, DK | ONF |
| Jul 22, 2014 | K141583 | SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY Shaser, Inc. | ONF |
| May 30, 2014 | K131712 | A-TONE IPL SYSTEM Ybk Investment, Inc. | ONF |
| May 16, 2014 | K140631 | LUMENA FH HAIR REMOVAL SYSTEM Shaser, Inc. | ONF |
| Feb 12, 2014 | K133201 | SHASER V-MINI 2 HAIR REMOVAL SYSTEM Shaser, Inc. | ONF |
| Dec 11, 2013 | K131649 | ME Syneron Beauty , Ltd. | ONF |
| Nov 26, 2013 | K132170 | SHASER V-MINI RX Shaser, Inc. | ONF |
| Oct 18, 2013 | K131859 | MULTIFUNCTIONAL SERIES Beijing Honkon Technologies Co., Ltd., CN | ONF |
| Sep 30, 2013 | K132266 | SHASER HRS2 RX HAIR REMOVAL SYSTEM Shaser, Inc. | ONF |
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