Product code ONF
- Product
- Powered Light Based Non-laser Surgical Instrument With Thermal Effect
- 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 D
- Description
- General & Plastic Surgery General Optical Products / Medical
- Regulation number
- 878.4810
- Radiation type
- Optical
- Applicable standards
- No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
Current FDA Classification
- Device name
- Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4810
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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.
Related Records
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
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| K231952 | MEDILIGHT | Medicreations, LLC | 2025-09-03 |
| K243123 | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025-07-03 |
| K250281 | DEKA LOTUS | El.En S.P.A. | 2025-02-26 |
| K242440 | Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. | 2024-11-14 |
| K240314 | MULA (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | 2024-08-21 |
| K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 |
| K233473 | DEKA LOTUS | El.En S.P.A. | 2024-05-16 |
| K233307 | Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. | 2024-03-15 |
| K232708 | Intense pulsed light therapy device | Hebei Zhemai Technology Co., Ltd. | 2023-12-01 |
| K232192 | Venus Versa PRO System | Venus Concept, Inc. | 2023-09-11 |
| K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 |
| K230816 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2023-04-21 |
| K220214 | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | 2023-02-18 |
| K220794 | 10PL | Tentech Co. , Ltd. | 2022-11-10 |
| 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 |
| K220385 | Intense Pulsed Light Equipment | Beijing Globalipl Development Co., Ltd. | 2022-08-12 |
| K213558 | IPL Hair Removal Device | Ulike Co., Ltd. | 2022-03-08 |
| K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products , Ltd. | 2021-12-02 |
| K211368 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | 2021-10-04 |
| K212099 | Red Wave Hair Removal | Shenzhen Accompany Technology Co., Ltd. | 2021-09-24 |
| K210119 | IPL Hair Removal Device (Model: KCA423) | Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. | 2021-05-21 |
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| K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-15 |
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| K193072 | Lucent : IPL | Luvo Medical Technologies, Inc. | 2020-03-05 |
| K192521 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2019-12-06 |
| K192519 | Multi-modality workstation | Beijing Superlaser Technology Co., Ltd. | 2019-11-27 |
| K181868 | SHINY RPL System | Ids, Ltd. | 2018-10-05 |
| K181298 | Harmony XL Multi-Application Platform | Alma Lasers, Inc. | 2018-06-13 |
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| 00860015460622 | NextGen Aesthetics IPL | T AESTHETICS LLC | 2026-03-12 |
| 00860009525146 | MediLight | MEDICREATIONS LLC | 2026-02-11 |
| 08034108513317 | DEKA LUXEA PLUS | DEKA M.E.L.A. SRL | 2025-12-16 |
| 06974851083014 | BVLASER | Nanjing Bestview Laser S&T Co.,Ltd. | 2024-11-27 |
| 06976573489105 | Bilens | Shanghai Bele Medical Technology Co., Ltd. | 2024-11-24 |
| 06928258000891 | GSD | Shenzhen GSD Tech Co., Ltd. | 2024-09-30 |
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| 07290019863151 | Lumecca Peak | INMODE M.D LTD | 2024-08-15 |
| 08809709380411 | 10PL | TENTECH Inc. | 2024-06-28 |
| 08809709380435 | 10PL | TENTECH Inc. | 2024-06-28 |
| 00850062978003 | WORLD AESTHETIX BROAD PULSED LIGHT | WORLD AESTHETIX LLC | 2024-06-25 |
| 07898961835020 | IPL-Sq | VYDENCE MEDICAL | 2024-05-27 |
| 07290016633955 | Lumecca I | INMODE M.D LTD | 2024-05-16 |
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