FDA 510(k)

强脉冲光系统（ST-690）

K号: K240482 · 2024-05-17

申请人Smedtrum Medical Technology Co., Ltd.

决定日期2024-05-17

产品代码ONF

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决定实质等同

器械摘要

Intense Pulsed Light System (ST-690) is the device name listed in this FDA 510(k) record. The listed applicant is Smedtrum Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-17 under 510(k) number K240482. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intense Pulsed Light System (ST-690)?

Intense Pulsed Light System (ST-690) is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Smedtrum Medical Technology Co., Ltd.. The 510(k) number is K240482.

When did Intense Pulsed Light System (ST-690) receive FDA 510(k) clearance?

Intense Pulsed Light System (ST-690) received FDA 510(k) clearance on 2024-05-17, under 510(k) number K240482.

Who is the listed applicant for Intense Pulsed Light System (ST-690)?

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

What is the FDA product code for Intense Pulsed Light System (ST-690)?

The FDA product code for Intense Pulsed Light System (ST-690) is ONF.

列明Smedtrum 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。

K240118皮秒 Nd:YAG 激光系统 K231394强脉冲光系统 K230580二极管激光系统 K221597CO2 激光系统

官方来源

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