OHV
- 产品代码
- OHV
- 器械名称
- Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4590
- 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)
- 9 件
- 其中 Summary 已存档
- 9 份,可直接下载
- FDA 历史累计 510(k)
- 30 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.
该代码近三年的 510(k)(9 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260618 | 2026-05-21 | Ulthera, Inc. | Ulthera® System | |
| K250418 | 2025-05-13 | Ulthera, Inc. | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | |
| K243035 | 2025-02-24 | Ulthera, Inc. | Ulthera® System | |
| K240687 | 2024-05-30 | Sofwave Medical, Ltd. | SofWave System | |
| K233996 | 2024-02-22 | Ulthera, Inc. | Ulthera System (UC-1 Control Unit PRIME) | |
| K233104 | 2023-12-22 | Sofwave Medical, Ltd. | SofWave System | |
| K232455 | 2023-12-14 | Sofwave Medical, Ltd. | SofWave System | |
| K230100 | 2023-11-03 | Classys, Inc. | SCIZER (SC1-M410) | |
| K231628 | 2023-09-29 | Beshape Technologies , Ltd. | BeShape One Device |
FDA 官方分类页: OHV
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。