ONF
74 FDA 510(k) clearances · Product code
113 daysmedian time to decision
276 days90th percentile
74clearances measured
FDA profile
- Official device name
- Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA definition
- A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Intense Pulsed Light Therapy Device (K261204) | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 |
| Intense Pulsed Light Therapy Device (MMABM-1) (K251545) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025-09-04 |
| MEDILIGHT (K231952) | Medicreations, LLC | 2025-09-03 |
| IPL Treatment Device (MDSQMC-01) (K243123) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025-07-03 |
| DEKA LOTUS (K250281) | El.En S.P.A. | 2025-02-26 |
| Intense Pulsed Light Treatment System (LK-PT) (K242440) | Nanjing Bestview Laser S&T Co., Ltd. | 2024-11-14 |
| MULA (K2-A1) (K240314) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | 2024-08-21 |
| Intense Pulsed Light System (ST-690) (K240482) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 |
| DEKA LOTUS (K233473) | El.En S.P.A. | 2024-05-16 |
| Intensity Pulsed Light Therapy System (K233307) | Beijing Adss Development Co., Ltd. | 2024-03-15 |
| Intense pulsed light therapy device (K232708) | Hebei Zhemai Technology Co., Ltd. | 2023-12-01 |
| Venus Versa PRO System (K232192) | Venus Concept, Inc. | 2023-09-11 |
| Intense Pulsed Light System (K231394) | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 |
| Intense Pulsed Light Treatment System (K230816) | Shangdong Huamei Technology Co., Ltd. | 2023-04-21 |
| Painless IPL System - KDT750 (K220214) | Shanghai Omni Laser Skinology Co., Ltd. | 2023-02-18 |
| 10PL (K220794) | Tentech Co. , Ltd. | 2022-11-10 |
| Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 (K221214) | Shenzhen Ionka Medical Technology Co., Ltd. | 2022-09-21 |
| Intense Pulsed Light Equipment (K220385) | Beijing Globalipl Development Co., Ltd. | 2022-08-12 |
| IPL Hair Removal Device (K213558) | Ulike Co., Ltd. | 2022-03-08 |
| Aimanfun Lumea Comfort, A-2789/A-3588 (K212907) | Kam Yuen Plastic Products , Ltd. | 2021-12-02 |
| IPL Hair Remover, Model: G993, G996, G998 and G885 (K211368) | Shenzhen Mywin Technology Co., Ltd. | 2021-10-04 |
| Red Wave Hair Removal (K212099) | Shenzhen Accompany Technology Co., Ltd. | 2021-09-24 |
| IPL Hair Removal Device (Model: KCA423) (K210119) | Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. | 2021-05-21 |
| E>EyeC (K200616) | E-Swin | 2020-06-11 |
| IPL Treatment Systems (K200746) | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-15 |
| IPL + Diode Laser Machine (K193328) | Beijing Globalipl Development Co., Ltd. | 2020-03-25 |
| Lucent : IPL (K193072) | Luvo Medical Technologies, Inc. | 2020-03-05 |
| Intense Pulsed Light Treatment System (K192521) | Shangdong Huamei Technology Co., Ltd. | 2019-12-06 |
| Multi-modality workstation (K192519) | Beijing Superlaser Technology Co., Ltd. | 2019-11-27 |
| SHINY RPL System (K181868) | Ids, Ltd. | 2018-10-05 |
| Harmony XL Multi-Application Platform (K181298) | Alma Lasers, Inc. | 2018-06-13 |
| DUO (K161565) | Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd | 2016-09-01 |
| IPL Therapy Machine (K161286) | Beijing Adss Development Co., Ltd. | 2016-08-04 |
| Forma System, Forma Light System (K160195) | Formatk Systems , Ltd. | 2016-04-15 |
| Venus Versa System (K153717) | Venus Concept , Ltd. | 2016-03-21 |
| Venus Versa System (K152790) | Venus Concept , Ltd. | 2016-01-20 |
| Shaser Skin Beauty Intense Pulsed Light System Family for Acne (K150282) | Shaser, Inc. | 2015-05-27 |
| Exilite (K150051) | BTL Industries, Inc. | 2015-04-08 |
| HARMONY LITE (K141237) | Alma, Inc. | 2015-03-13 |
| PLATINUMGMT IPL SYSTEM CLOUD (K140668) | Global Medical Technology S.L. | 2014-12-19 |
| Mini me (K143339) | Iluminage Ltd.(Formerly Syneron Beauty Ltd.) | 2014-12-19 |
| ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ (K140670) | Ellipse A/S | 2014-09-25 |
| SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY (K141583) | Shaser, Inc. | 2014-07-22 |
| A-TONE IPL SYSTEM (K131712) | Ybk Investment, Inc. | 2014-05-30 |
| LUMENA FH HAIR REMOVAL SYSTEM (K140631) | Shaser, Inc. | 2014-05-16 |
| SHASER V-MINI 2 HAIR REMOVAL SYSTEM (K133201) | Shaser, Inc. | 2014-02-12 |
| ME (K131649) | Syneron Beauty , Ltd. | 2013-12-11 |
| SHASER V-MINI RX (K132170) | Shaser, Inc. | 2013-11-26 |
| MULTIFUNCTIONAL SERIES (K131859) | Beijing Honkon Technologies Co., Ltd. | 2013-10-18 |
| SHASER HRS2 RX HAIR REMOVAL SYSTEM (K132266) | Shaser, Inc. | 2013-09-30 |
| SHASER V-MINI HAIR REMOVAL SYSTEM (K130015) | Shaser, Inc. | 2013-06-13 |
| INMODE SR IPL DEVICE (K123860) | Inmode MD , Ltd. | 2013-04-02 |
| ACLEARA, THERACLEAR (K123889) | Theravant Corporation | 2013-03-04 |
| IPL THERAPY SYSTEM (K123435) | Beijing Sincoheren S&T Development Co, Ltd. | 2013-02-11 |
| INTENSE PULSED LIGHT (IPL) SYSTEMS (K122995) | Beijing Kes Biology Technology Co., Ltd. | 2013-01-22 |
| ME (K123845) | Syneron Beauty , Ltd. | 2013-01-10 |
| ME HAIR2GO (K121598) | Syneron Medical, Ltd. | 2012-10-12 |
| ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM (K121515) | Solta Medical, Inc. | 2012-06-05 |
| SHASER HRS2 HAIR REMOVAL SYSTEM (K120080) | Shaser, Inc. | 2012-05-25 |
| MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM (K111350) | Medicam, Inc. | 2011-09-29 |
| SHASER IPL HAIR REMOVAL SYSTEM (K103560) | Shaser, Inc. | 2011-05-18 |
| IPL THERAPY SYSTEM (K101901) | Beijing Starlight Science & Technology Development | 2011-03-08 |
| IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650 (K093627) | Shanghai Apolo Medical Technologies Co., Ltd. | 2011-01-18 |
| AHWON'S IPL SYSTEM (K102857) | Ahwon Medi Instrument Co., Ltd. | 2011-01-14 |
| MEDIFLASH AND ESTEFLASH (K093168) | Dermeo | 2010-05-21 |
| MATTIOLI PULSE TWO/THREE PLUS FAMILY (K100053) | Mattioli Engineering Corp. | 2010-03-10 |
| SMOOTHCOOL (K092326) | Jeisys Medical, Inc. | 2010-03-05 |
| FUSION SYSTEM (K093465) | Eclipsemed Global, Inc. | 2010-01-05 |
| GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C (K091664) | Shenzhen Gsd Tech Co., Ltd. | 2009-11-16 |
| OR-LIGHT (K090724) | Yperion Technology | 2009-10-07 |
| MINISILK FT (K082040) | El.En Electronic Engineering Spa | 2009-08-27 |
| STRATAPULSE TS AND STRATAPULSE (K090837) | Advanced Medical Photonics | 2009-06-17 |
| TRIOS SYSTEM (K090399) | Viora , Ltd. | 2009-06-10 |
| ACCELAWAVE SYSTEM (K082484) | Genesis Biosystems, Inc. | 2008-09-12 |
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Every clearance here is in the API, with alerts when new ones post.