FDA 510(k)

強力パルス光装置、モデル：DE01A-B、DE01A-G、DE01B-B、DE01B-G、DE01C-B、DE01C-G、DE02A-B、DE02A-G、DE02B-B、DE02B-G、DE02C-B、DE02C-G。

K番号: K231613 · 2023-07-31

申請者Zhuzhou Goldenhot Medical Technology Co., Ltd.

決定日2023-07-31

製品コードOHT

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

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is the device name listed in this FDA 510(k) record. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K231613. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. The 510(k) number is K231613.

When did Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. receive FDA 510(k) clearance?

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. received FDA 510(k) clearance on 2023-07-31, under 510(k) number K231613.

Who is the listed applicant for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

The FDA 510(k) record lists Zhuzhou Goldenhot Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

The FDA product code for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is OHT.

申請者としてZhuzhou Goldenhot Medical Technology Co., Ltd.を記載するその他の記録

K243085IPLヘア除去装置（DE03A-W、DE03A-P、DE03A-V、DE03A-G、DE03B-W、DE03B-P、DE03B-V、DE03B-G）K240109医療用電子体温計（FC01、FC02）

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。