FDA 510(k)

LEDライトセラピー maszker（モデル：T2、RLD10）

K番号: K254079 · 2026-03-16

決定日2026-03-16

製品コードOHS

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

LED Light Therapy Mask (Models: T2, RLD10) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Desida Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K254079. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the LED Light Therapy Mask (Models: T2, RLD10)?

LED Light Therapy Mask (Models: T2, RLD10) is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Shenzhen Desida Technology Co., Ltd.. The 510(k) number is K254079.

When did LED Light Therapy Mask (Models: T2, RLD10) receive FDA 510(k) clearance?

LED Light Therapy Mask (Models: T2, RLD10) received FDA 510(k) clearance on 2026-03-16, under 510(k) number K254079.

Who is the listed applicant for LED Light Therapy Mask (Models: T2, RLD10)?

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

What is the FDA product code for LED Light Therapy Mask (Models: T2, RLD10)?

The FDA product code for LED Light Therapy Mask (Models: T2, RLD10) is OHS.

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

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