Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)— 510(k) K240649
Substantially EquivalentShenzhen Ulike Smart Electronics Co., Ltd.
FDA 510(k) clearance K240649 for Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW), Substantially Equivalent on 2024-06-21. Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Ulike Smart Electronics Co., Ltd.
- Product code
- Code OHT
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OHT
view all- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
- K261325 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
- K260594 — IPL 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)
- K260742 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
- K260518 — IPL 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)
More clearances from Shenzhen Ulike Smart Electronics Co., Ltd.
view all- K260511 — Ulike Reglow Light Therapy Device (UM10)
- K251825 — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
- K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG +4 more
- K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
- K250942 — 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.