ONF — Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Class II
Classification Details
- Product Code
- ONF
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251545 | micowey medical equipment (guangxi) co | Intense Pulsed Light Therapy Device (MMABM-1) | September 4, 2025 |
| K231952 | medicreations | MEDILIGHT | September 3, 2025 |
| K243123 | medusa (guangxi)medical devices co | IPL Treatment Device (MDSQMC-01) | July 3, 2025 |
| K250281 | el.en | DEKA LOTUS | February 26, 2025 |
| K242440 | nanjing bestview laser s and t co | Intense Pulsed Light Treatment System (LK-PT) | November 14, 2024 |
| K240314 | guangzhou ciellulu photoelectric technology co | MULA (K2-A1) | August 21, 2024 |
| K240482 | smedtrum medical technology co | Intense Pulsed Light System (ST-690) | May 17, 2024 |
| K233473 | el.en | DEKA LOTUS | May 16, 2024 |
| K233307 | beijing adss development co | Intensity Pulsed Light Therapy System | March 15, 2024 |
| K232708 | hebei zhemai technology co | Intense pulsed light therapy device | December 1, 2023 |
| K232192 | venus concept | Venus Versa PRO System | September 11, 2023 |
| K231394 | smedtrum medical technology co | Intense Pulsed Light System | August 9, 2023 |
| K230816 | shangdong huamei technology co | Intense Pulsed Light Treatment System | April 21, 2023 |
| K220214 | shanghai omni laser skinology co | Painless IPL System - KDT750 | February 18, 2023 |
| K220794 | tentech co. | 10PL | November 10, 2022 |
| K221214 | shenzhen ionka medical technology co | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, F | September 21, 2022 |
| K220385 | beijing globalipl development co | Intense Pulsed Light Equipment | August 12, 2022 |
| K213558 | ulike co | IPL Hair Removal Device | March 8, 2022 |
| K212907 | kam yuen plastic products | Aimanfun Lumea Comfort, A-2789/A-3588 | December 2, 2021 |
| K211368 | shenzhen mywin technology co | IPL Hair Remover, Model: G993, G996, G998 and G885 | October 4, 2021 |