FDA 510(k)

强脉冲光治疗系统（LK-PT）

K号: K242440 · 2024-11-14

决定日期2024-11-14

产品代码ONF

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决定实质等同

器械摘要

Intense Pulsed Light Treatment System (LK-PT) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K242440. 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 Treatment System (LK-PT)?

Intense Pulsed Light Treatment System (LK-PT) is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K242440.

When did Intense Pulsed Light Treatment System (LK-PT) receive FDA 510(k) clearance?

Intense Pulsed Light Treatment System (LK-PT) received FDA 510(k) clearance on 2024-11-14, under 510(k) number K242440.

Who is the listed applicant for Intense Pulsed Light Treatment System (LK-PT)?

The FDA 510(k) record lists Nanjing Bestview Laser S&T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intense Pulsed Light Treatment System (LK-PT)?

The FDA product code for Intense Pulsed Light Treatment System (LK-PT) is ONF.

列明Nanjing Bestview Laser S&T 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。

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官方来源

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