510(k) K250281
- Device
- DEKA LOTUS
- Applicant
- El.En S.P.A.
- 510(k) number
- K250281
- Product code
- ONF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-26
- Date received
- 2025-01-31
- Regulation
- 878.4810
- Classification name
- Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Peruzzi Paolo
- Address
- Via Baldanzese, 17 Calenzano IT 50041 50041
FDA Registration Numbers
- 3007113239
- 3038715747
- 3033793026
- 3006515340
- 3023281259
- 3043140693
- 2953696
- 3043657394
- 3022327202
- 3030230686
- 9680762
- 1313525
- 1222304
- 3043655996
- 3009040934
- 3034995492
- 3009488834
- 3037874486
- 3008442971
- 3027605738
- 3027645761
- 3005855240
- 3043011436
- 3013494333
- 3010511300
- 3004167969
- 3033844600
- 3041275224
- 3009444646
- 3011423170
- 3013602304
- 8040564
- 3016661372
- 3011782009
- 3033482500
- 3043047259
- 3017905264
- 3027725665
- 3033715699
- 3043012240
- 3003542872
- 3007085226
- 3017200975
- 3004635398
- 3011964664
- 3002808227
- 3005695724
- 3025104654
- 3008915316
- 3016170453
- 3006580954
- 3025606176
- 3026540840
- 3010273872
- 3011670002
- 3010627091
- 3006985163
- 3033884002
- 3010902869
- 3009736547
- 3007084556
- 3008925277
- 3006555617
- 3021011208
- 3005238200
- 3012133441
- 3007238544
- 3011307265
- 3016076698
- 3034246188
- 3011070163
- 3006716777
- 3010027944
- 3001431138
- 3010912900
- 3009019578
- 2031934
- 3012772112
- 3043127589
- 3032147807
Source Documents
Other 510(k) Records For Product Code ONF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251545 | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025-09-04 |
| K231952 | MEDILIGHT | Medicreations, LLC | 2025-09-03 |
| K243123 | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025-07-03 |
| K242440 | Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. | 2024-11-14 |
| K240314 | MULA (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | 2024-08-21 |
| K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 |
| K233473 | DEKA LOTUS | El.En S.P.A. | 2024-05-16 |
| K233307 | Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. | 2024-03-15 |
| K232708 | Intense pulsed light therapy device | Hebei Zhemai Technology Co., Ltd. | 2023-12-01 |
| K232192 | Venus Versa PRO System | Venus Concept, Inc. | 2023-09-11 |
| K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 |
| K230816 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2023-04-21 |
| K220214 | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | 2023-02-18 |
| K220794 | 10PL | Tentech Co. , Ltd. | 2022-11-10 |
| K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 | Shenzhen Ionka Medical Technology Co., Ltd. | 2022-09-21 |