FDA 510(k)

光纤激光治疗系统

K号: K221770 · 2022-10-13

申请人Shanghai Apolo Medical Technology Co., Ltd.

决定日期2022-10-13

产品代码ONG

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决定实质等同

器械摘要

Fiber Laser Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K221770. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fiber Laser Treatment System?

Fiber Laser Treatment System is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K221770.

When did Fiber Laser Treatment System receive FDA 510(k) clearance?

Fiber Laser Treatment System received FDA 510(k) clearance on 2022-10-13, under 510(k) number K221770.

Who is the listed applicant for Fiber Laser Treatment System?

The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fiber Laser Treatment System?

The FDA product code for Fiber Laser Treatment System is ONG.

列明Shanghai Apolo Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260256Q-Switched Nd: YAG Laser Systems K260017皮秒 Nd:YAG 激光系统（型号：HS-298）K251031光纤激光治疗系统（HS-232，HS-233）K232409电磁刺激系统 K203395平台治疗系统 K201731二极管激光身体雕塑系统

查看所有 14 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。