FDA 510(k)

アイスクールIPLヘアレーザー脱毛装置（UI20S DB、UI20S RE、UI20S PW、UI20S GP、UI20S GR、UI20S BK、UI20 DB、UI20 RE、UI20 PW、UI20 GP、UI20 GR、UI20 BK）

K番号: K250942 · 2025-07-11

申請者Shenzhen Ulike Smart Electronics Co., Ltd.

決定日2025-07-11

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Substantially Equivalent

医療機器の概要

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ulike Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K250942. 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 Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)?

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K250942.

When did Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) receive FDA 510(k) clearance?

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250942.

Who is the listed applicant for Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)?

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

What is the FDA product code for Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)?

The FDA product code for Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) is OHT.

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

K261325アイスクールIPLヘアレーザー脱毛装置（UI06S PR、UI06S PN、UI06S WH、UI06S PRU、UI06S PNU、UI06S WHU）K260742アイスクールIPLヘアレーザー脱毛装置（UI20S DB、UI20S RE、UI20S PW、UI20S GP、UI20S GR、UI20S BK）K260511Ulike Reglow Light Therapy Device (UM10)K252804アイスクールIPLヘアレーザー除去装置（UI20S BK、UI20S BS、UI20S DB、UI20S GP、UI20S GR、UI20S MP、UI20S PW、UI20S RE、UI20S WH、UI20WG；UI20 BK、UI20 BL、UI20 BR、UI20 BS、UI20 DB、UI20 GP、UI20 GR、UI20 MP、UI20 PN、UI20 PW、UI20 RE、UI20 WH；UI06 PN、UI06 PL、UI06 JL、UI06 BR、UI06 DB、UI06 PR、UI06 OG、UI06RD、UI06 WH、UI06 MG、UI06 OB、UI06 LY、UI06 IG；UI06S PR、UI06S PN、UI06S WH、UI06S PRU、UI06S PNU、UI06S WHU；UI04 MK、UI04 BN、UI04 BU、UI04 CB、UI04 GY、UI04 LG、UI04 DG、UI04 PL）K251825Jmoon FlexGlow 光療装置（JD20U SP、JD20U SG）K251984アイスクールIPLヘアレーザー脱毛装置（UI06S PR、UI06S PN、UI06S WH、UI06S PRU、UI06S PNU、UI06S WHU）

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