FDA 510(k)

強度脈衝光療法系統

K 號：K233307 · 2024-03-15

決定日期2024-03-15

產品代碼ONF

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Intensity Pulsed Light Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K233307. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Intensity Pulsed Light Therapy System?

Intensity Pulsed Light Therapy System is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K233307.

When did Intensity Pulsed Light Therapy System receive FDA 510(k) clearance?

Intensity Pulsed Light Therapy System received FDA 510(k) clearance on 2024-03-15, under 510(k) number K233307.

Who is the listed applicant for Intensity Pulsed Light Therapy System?

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

What is the FDA product code for Intensity Pulsed Light Therapy System?

The FDA product code for Intensity Pulsed Light Therapy System is ONF.

其他以 Beijing Adss Development Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K241670分數二氧化碳激光療法系統 (FG900-S)；分數二氧化碳激光療法系統 (FG900-S2)K231896二極雷射治療系統 K231318電磁刺激器設備（型號 EM Contouring 和 Tesla Duet）K220268皮秒雷射系統（型號 PS10-A 及 PS10-B）K192295PDT-FACE K161926ND YAG Q-switch雷射治療機

查看所有 10 項裝置 →

相關器械（代碼：ONF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261204強烈脈衝光療法設備Sanhe LEFIS Electronics Co., Ltd.K251545強烈脈衝光療法設備（MMABM-1）Micowey Medical Equipment (Guangxi) Co., Ltd.K231952醫療設備名稱：MEDILIGHTMedicreations, LLC K243123IPL治療設備（MDSQMC-01）Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA 草莓El.En S.P.A.K242440強烈脈衝光治療系統（LK-PT）Nanjing Bestview Laser S&T Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。