FDA 510(k)

Q-Switched Nd:YAG レーザー（SHE-LSP101-1）

K番号: K250936 · 2025-06-12

申請者Beijing Sano Laser S&T Development Co.,Ltd

決定日2025-06-12

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Q-Switched Nd:YAG Laser (SHE-LSP101-1) 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 2025-06-12 under 510(k) number K250936. 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.

よくある質問

What is the Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

Q-Switched Nd:YAG Laser (SHE-LSP101-1) is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K250936.

When did Q-Switched Nd:YAG Laser (SHE-LSP101-1) receive FDA 510(k) clearance?

Q-Switched Nd:YAG Laser (SHE-LSP101-1) received FDA 510(k) clearance on 2025-06-12, under 510(k) number K250936.

Who is the listed applicant for Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

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 Q-Switched Nd:YAG Laser (SHE-LSP101-1)?

The FDA product code for Q-Switched Nd:YAG Laser (SHE-LSP101-1) is GEX. This falls under the Gastroenterology category.

申請者としてBeijing Sano Laser S&T Development Co.,Ltdを記載するその他の記録

K260690LumiGlamレーザーシステム（SHE-LSP601-3）K242941CO2レーザー治療システム（SHE-LSP003-1）K233416Cryojet Plus (SHE-ACP001-1)K230024HI-EMT マグシェイプ K191970レーザー脱毛システム

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。