QPB
- 产品代码
- QPB
- 器械名称
- System, Suction, Lipoplasty For Removal
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.5040
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 10 件
- 其中 Summary 已存档
- 9 份,可直接下载
- FDA 历史累计 510(k)
- 59 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
该代码近三年的 510(k)(10 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261710 | 2026-08-21 | Apyx Medical Corporation | AYON Power Liposuction Cannulas and AYON Power Lip… | |
| K251944 | 2026-06-08 | Lipocosm, LLC | Lipocosm Harmonic System | |
| K253396 | 2026-05-08 | Apyx Medical Corporation | AYON Body Contouring System (AYON SYSTEM) | |
| K252495 | 2026-04-03 | Newpong Co., Ltd. | LSSA (NP-200) | |
| K244050 | 2025-05-12 | Apyx Medical Corporation | AYON Body Contouring System (AYON SYSTEM) | |
| K244026 | 2025-04-25 | Microaire Surgical Instruments, LLC | PAL 7020 Console | |
| K242804 | 2024-12-30 | Microaire Surgical Instruments, LLC | PAL Aspiration System | |
| K241835 | 2024-11-27 | Cellmyx | AirSculpt Body Contouring System (AIRS-1-SYS) | |
| K240188 | 2024-09-13 | Black & Black Surgical, Inc. | Vitruvian Liposaber | FDA |
| K212969 | 2024-08-07 | Lhbiomed Co., Ltd. | Liposaver |
FDA 官方分类页: QPB
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。