FDA 510(k)

LumiGlam 激光系统 (SHE-LSP601-3)

K号: K260690 · 2026-06-04

申请人Beijing Sano Laser S&T Development Co.,Ltd

决定日期2026-06-04

产品代码GEX

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决定实质等同

器械摘要

LumiGlam Laser System (SHE-LSP601-3) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K260690. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the LumiGlam Laser System (SHE-LSP601-3)?

LumiGlam Laser System (SHE-LSP601-3) is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K260690.

When did LumiGlam Laser System (SHE-LSP601-3) receive FDA 510(k) clearance?

LumiGlam Laser System (SHE-LSP601-3) received FDA 510(k) clearance on 2026-06-04, under 510(k) number K260690.

Who is the listed applicant for LumiGlam Laser System (SHE-LSP601-3)?

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

What is the FDA product code for LumiGlam Laser System (SHE-LSP601-3)?

The FDA product code for LumiGlam Laser System (SHE-LSP601-3) is GEX. This falls under the Gastroenterology category.

列明Beijing Sano Laser S&T Development 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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