FDA 510(k) ClearanceGEX
Diode Laser Therapy System
FDA 510(k) K261562 · Sanhe LEFIS Electronics Co., Ltd.
Clearance details
Ask AI- 510(k) number
- K261562
- Device name
- Diode Laser Therapy System
- Applicant
- Sanhe LEFIS Electronics Co., Ltd.
- Product code
- GEX
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 878.4810
- Advisory committee
- SU
- Medical specialty
- General, Plastic Surgery
Candidate predicate devices
Ask AIOther devices cleared under product code GEX form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | |
| K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | |
| K252723 | Dynamis Pro Family | Fotona D.O.O. | |
| K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | |
| K261673 | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | |
| K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | |
| K262877 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | |
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | |
| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. |
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