Product areas
FDA product code distribution
FDA product code distribution
9 total
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K241699 | SUPER VELOCE | GEX | Class 2 | 2024-08-13 |
| K231791 | PENTO Nd:YAG and Alexandrite laser system | GEX | Class 2 | 2023-09-15 |
| K222555 | reepot Nd; YAG laser system | GEX | Class 2 | 2022-09-23 |
| K213250 | Secret Duo | GEX | Class 2 | 2022-06-24 |
| K202043 | Secret Duo | GEX | Class 2 | 2021-04-23 |
| K173038 | CuRAS Nd:YAG Laser | GEX | Class 2 | 2017-12-01 |
| K172096 | Fraxis | GEX | Class 2 | 2017-08-09 |
| K160312 | FRAXIS DUO | GEX | Class 2 | 2016-10-28 |
| K151232 | VIKINI Diode Laser System | GEX | Class 2 | 2015-08-06 |
CuRAS hybrid
SANDRO Dual
Q-Switched Nd: YAG Laser machine (LFS-C13U)
Sanhe Lefis Electronics Co., Ltd.
Fractional CO2 Laser Machine
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Fractional CO2 Laser Therapy System (EXFU CO2)
Weifang Mingliang Electronics Co., Ltd.
reepot Nd; YAG laser system
AROMA GRAND
Daeju Meditech Engineering Co., Ltd.
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Nd: YAG Laser Therapy Systems
Beijing Kes Biology Technology Co., Ltd.
Fraxis
Venus Velocity Diode Laser System
12 submissions cite Ilooda Co,., Ltd. as a predicate