Intense Pulsed Light Treatment System (LK-PT)
FDA 510(k) K242440 · Nanjing Bestview Laser S&T Co., Ltd.
Submission
- Device name
- Intense Pulsed Light Treatment System (LK-PT)
- Applicant
- Nanjing Bestview Laser S&T Co., Ltd.
Nanjing, CN - Received
- August 16, 2024
- Decision date
- November 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONF – Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
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…
Other 510(k)s with product code ONF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261204 | Intense Pulsed Light Therapy DeviceONF · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 06/12/2026SE |
| K251545 | Intense Pulsed Light Therapy Device (MMABM-1)ONF · Traditional | Micowey Medical Equipment (Guangxi) Co., Ltd. | 09/04/2025SE |
| K231952 | MedilightONF · Special | Medicreations, LLC | 09/03/2025SE |
| K243123 | IPL Treatment Device (MDSQMC-01)ONF · Traditional | Medusa (Guangxi)Medical Devices Co., Ltd. | 07/03/2025SE |
| K250281 | Deka LotusONF · Special | El.En S.P.A. | 02/26/2025SE |
| K240314 | Mula (K2-A1)ONF · Traditional | Guangzhou Ciellulu Photoelectric Technology Co.… | 08/21/2024SE |
| K240482 | Intense Pulsed Light System (ST-690)ONF · Traditional | Smedtrum Medical Technology Co., Ltd. | 05/17/2024SE |
| K233473 | Deka LotusONF · Traditional | El.En S.P.A. | 05/16/2024SE |
| K233307 | Intensity Pulsed Light Therapy SystemONF · Traditional | Beijing Adss Development Co., Ltd. | 03/15/2024SE |
| K232708 | Intense pulsed light therapy deviceONF · Traditional | Hebei Zhemai Technology Co., Ltd. | 12/01/2023SE |
More from Hebei Zhemai Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260974 | CO2 Laser Machine (Monica-I,Monica-II)GEX · Traditional | 05/07/2026SE |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q)GEX · Traditional | 04/20/2026SE |
| K251919 | Thulium Laser System (Deluxlase)GEX · Traditional | 09/26/2025SE |
| K250465 | CO2 Laser Machine (Lume)GEX · Traditional | 06/09/2025SE |
Questions and answers
When was Intense Pulsed Light Treatment System (LK-PT) cleared by the FDA?
Intense Pulsed Light Treatment System (LK-PT) (K242440) received a 510(k) decision of Substantially Equivalent on November 14, 2024, 90 days after the submission was received.
What is the product code of K242440?
The FDA product code is ONF – Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, a Class II (moderate risk) device regulated under 21 CFR 878.4810.