非侵入身体塑形器械在FDA的分类
Technology 技术 | Product code 产品代码 | Regulation(21 CFR) 法规(21 CFR)
| Device Type 器械类型 |
Cryolipolysis 冷冻凝脂术 | OOK | 878.4340 | Cooling with vacuum for body contouring 采用真空冷却进行身体塑形的器械 |
Radiofrequency Energy 射频能量 | GEI | 878.4400 | Electrosurgical (including RF) 电外科手术（包括射频）器械 |
Radiofrequency Energy 射频能量 | PBX | 878.4400 | Vacuum massager with RF-induced heating 采用射频诱导加热的真空按摩仪 |
Light-based Energy 基于光的能量 | GEX | 878.4810 | Powered laser surgical instrument 动力激光手术器械 |
Light-based Energy 基于光的能量 | PKT | 878.5400 | Laser for disruption of fat for aesthetic use 美容使用分解脂肪的激光器械 |
Ultrasound 超声 | OHV | 878.4590 | Focused ultrasound for tissue heat or cell disruption 用于组织热或细胞分解的聚焦超声波器械
|
Low level light (laser) 低级光（激光） | OLI | 878.5400 | Low level light (laser) for fat reduction 用于脂肪减少的低级光（激光）器械 |
Magnetic Field 磁场 | NGX | 890.5850 | Muscle stimulator 肌肉刺激仪 |
Mechanical (Massage or Vibration) 机械（按摩或振动） | NUV | 878.4810 | Vacuum massager with light-induced heating for cellulite appearance 对脂肪团外观采用光诱导加热的真空按摩仪
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