FDA 510(k)

IPLヘア除去デバイス（モデル：T31A、T32A）

K番号: K253666 · 2026-02-23

申請者Shenzhen Mlay Intelligent Technology Co., Ltd.

決定日2026-02-23

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

IPL Hair Removal Device (Models: T31A, T32A) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mlay Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K253666. 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 IPL Hair Removal Device (Models: T31A, T32A)?

IPL Hair Removal Device (Models: T31A, T32A) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Shenzhen Mlay Intelligent Technology Co., Ltd.. The 510(k) number is K253666.

When did IPL Hair Removal Device (Models: T31A, T32A) receive FDA 510(k) clearance?

IPL Hair Removal Device (Models: T31A, T32A) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253666.

Who is the listed applicant for IPL Hair Removal Device (Models: T31A, T32A)?

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

What is the FDA product code for IPL Hair Removal Device (Models: T31A, T32A)?

The FDA product code for IPL Hair Removal Device (Models: T31A, T32A) is OHT.

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

K251176IPLヘア除去デバイス（モデル：T14B、T16B、T19B、T15B、T17C、T18B、T21A、T21B、T21C、T21D、T22A、T22B、T25B、T25C）K241106アイスクール IPL ホーム用毛脱毛デバイス（モデル：T10B、T10C、T15A、T17A、T18A、T14A、T16A、T19A）K240264家庭用毛髪除去機器（モデル：T10A、T10B、T10C、T10D、T11A、T15A、T17A、T18A、T14A、T16A、T19A）

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