FDA 510(k)

라미글램 레이저 시스템 (SHE-LSP601-3)

K-번호: K260690 · 2026-06-04

신청자Beijing Sano Laser S&T Development Co.,Ltd

결정일2026-06-04

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Beijing Sano Laser S&T Development Co.,Ltd를 신청인으로 등재한 기타 기록

K250936Q-Switched Nd:YAG 레이저 (SHE-LSP101-1)K242941CO2 레이저 치료 시스템 (SHE-LSP003-1)K233416Cryojet Plus (SHE-ACP001-1)K230024HI-EMT 마그셔프 K191970다이오드 레이저 헤어 레이저 제거 시스템

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