Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
FDA product code distribution
6 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) | GEX | Class 2 | 2025-04-04 |
| K240747 | Medical Diode Laser (M2-GK) | GEX | Class 2 | 2024-06-17 |
| K240644 | Medical Diode Laser (S1Pro) | GEX | Class 2 | 2024-06-10 |
| K240179 | Medical Diode Laser (Model: L2) | GEX | Class 2 | 2024-03-21 |
| K231548 | Medical Diode Laser, Model S1Pro | GEX | Class 2 | 2023-08-03 |
| K230274 | Medical Diode Laser (M2) | GEX | Class 2 | 2023-03-31 |
Medical Diode Laser (M2)
Medical Diode Laser (Model: L2)
Medical Diode Laser (M2-GK)
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neoV980 & neoV1470 Diode Lasers
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neoV980 & neoV1470 Diode Lasers
Medical Diode Laser, Model S1Pro
SkyPulse
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Medical Diode Laser Systems
SkyPulse
Wuhan Pioon Technology Co., Ltd. references 12 predicate/reference devices
Medical Diode Laser Systems (TR-B)
SurgiLight 1470 Diode Laser System (Model:Halo)
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
Heager Medical Laser Family (Sabrina/Adolf)
Diode Laser System model Dawn-S
Diode Laser System model Dawn-S
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
Medical Diode Laser (S1Pro)
10 submissions cite Wuhan Pioon Technology Co., Ltd. as a predicate