DEKA LOTUS
FDA 510(k) clearance K233473 · decided 2024-05-16
Clearance details
- K-number
- K233473
- Device name
- DEKA LOTUS
- Applicant
- El.En S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2023-10-25
- Decision date
- 2024-05-16
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- ONF
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Calenzano, IT
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Intense Pulsed Light Therapy Device (K261204) | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 |
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| IPL Treatment Device (MDSQMC-01) (K243123) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025-07-03 |
| DEKA LOTUS (K250281) | El.En S.P.A. | 2025-02-26 |
| Intense Pulsed Light Treatment System (LK-PT) (K242440) | Nanjing Bestview Laser S&T Co., Ltd. | 2024-11-14 |
| MULA (K2-A1) (K240314) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | 2024-08-21 |
| Intense Pulsed Light System (ST-690) (K240482) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 |
| Intensity Pulsed Light Therapy System (K233307) | Beijing Adss Development Co., Ltd. | 2024-03-15 |
| Intense pulsed light therapy device (K232708) | Hebei Zhemai Technology Co., Ltd. | 2023-12-01 |
| Venus Versa PRO System (K232192) | Venus Concept, Inc. | 2023-09-11 |
| Intense Pulsed Light System (K231394) | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 |
Recalls involving this device
No recalls on record reference this clearance.