Mini me
FDA 510(k) clearance K143339 · decided 2014-12-19
Clearance details
- K-number
- K143339
- Device name
- Mini me
- Applicant
- Iluminage Ltd.(Formerly Syneron Beauty Ltd.)
- Decision
- Substantially Equivalent
- Date received
- 2014-11-20
- Decision date
- 2014-12-19
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- ONF
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Yokneam Illit, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Iluminage Ltd.(Formerly Syneron Beauty Ltd.)
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Intense Pulsed Light Therapy Device (K261204) | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 |
| Intense Pulsed Light Therapy Device (MMABM-1) (K251545) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025-09-04 |
| MEDILIGHT (K231952) | Medicreations, LLC | 2025-09-03 |
| 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 |
| DEKA LOTUS (K233473) | El.En S.P.A. | 2024-05-16 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.