결정일2026-05-21
제품 코드OHT
자문 위원회SU
결정Substantially Equivalent
기기 요약
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) 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 2026-05-21 under 510(k) number K261325. 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 (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)?
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Shenzhen Ulike Smart Electronics Co., Ltd.. The 510(k) number is K261325.
When did Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) receive FDA 510(k) clearance?
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K261325.
Who is the listed applicant for Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)?
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 (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)?
The FDA product code for Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) is OHT.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
Shenzhen Ulike Smart Electronics Co., Ltd.를 신청인으로 등재한 기타 기록
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)K260511Ulike Reglow Light Therapy Device (UM10)K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)K252804Ice Cooling IPL Hair Removal Device (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,K251984Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)K250942Ice 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) 23개 장치 모두 보기 →
관련 기기 (코드: OHT)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
K261977Braun Aura 9 (6042)Cyden LimitedK262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic Co., Ltd.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)Shenzhen Semlamp Intelligent Technology Co., Ltd.
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.