Mula (K2-A1)
FDA 510(k) K240314 · Guangzhou Ciellulu Photoelectric Technology Co., Ltd.
Submission
- Device name
- Mula (K2-A1)
- Applicant
- Guangzhou Ciellulu Photoelectric Technology Co., Ltd.
Guangzhou, CN - Received
- February 2, 2024
- Decision date
- August 21, 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 |
| K242440 | Intense Pulsed Light Treatment System (LK-PT)ONF · Traditional | Nanjing Bestview Laser S&T Co., Ltd. | 11/14/2024SE |
| 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 |
Questions and answers
When was Mula (K2-A1) cleared by the FDA?
Mula (K2-A1) (K240314) received a 510(k) decision of Substantially Equivalent on August 21, 2024, 201 days after the submission was received.
What is the product code of K240314?
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.