Deka Lotus
FDA 510(k) K250281 · El.En S.P.A.
510(k) numberK250281
Submission
- Device name
- Deka Lotus
- Applicant
- El.En S.P.A.
Calenzano, IT - Received
- January 31, 2025
- Decision date
- February 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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…
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| 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 |
| K242440 | Intense Pulsed Light Treatment System (LK-PT)ONF · Traditional | Nanjing Bestview Laser S&T Co., Ltd. | 11/14/2024SE |
| 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 |
|---|---|---|
| K260647 | SpecchioPBX · Special | 04/02/2026SE |
| K251432 | OloGEX · Traditional | 08/06/2025SE |
| K243683 | Deka BluebeamGEX · Traditional | 06/12/2025SE |
| K241459 | MOTUS PRO FamilyGEX · Special | 06/21/2024SE |
| K240752 | Deka ToroGEX · Traditional | 05/16/2024SE |
| K233473 | Deka LotusONF · Traditional | 05/16/2024SE |
| K234057 | NirvanaGEX · Traditional | 04/10/2024SE |
| K240537 | Smartxide ProGEX · Special | 03/20/2024SE |
| K240497 | Smartxide Tetra ProGEX · Special | 03/12/2024SE |
| K233470 | Deka LilyNGX · Traditional | 12/19/2023SE |
Questions and answers
When was Deka Lotus cleared by the FDA?
Deka Lotus (K250281) received a 510(k) decision of Substantially Equivalent on February 26, 2025, 26 days after the submission was received.
What is the product code of K250281?
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.