FDA 510(k)

아이스 쿨링 IPL 헤어 레이저 제거 장치 (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-번호: K250942 · 2025-07-11

신청자Shenzhen Ulike Smart Electronics Co., Ltd.

결정일2025-07-11

제품 코드OHT

자문 위원회SU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Shenzhen Ulike Smart Electronics Co., Ltd.를 신청인으로 등재한 기타 기록

K261325아이스 쿨링 IPL 헤어 레이저 제거 장치 (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)K260742아이스 쿨링 IPL 헤어 레이저 제거 장치 (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)K260511Ulike Reglow Light Therapy Device (UM10)K252804아이스 쿨링 IPL 헤어 레이저 디바이스 (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 조명 치료 장치 (JD20U SP, JD20U SG)K251984아이스 쿨링 IPL 헤어 레이저 제거 장치 (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

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