IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4— 510(k) K220222
Substantially EquivalentShenzhen Yuwei Electronic Technology Co., Ltd.
FDA 510(k) clearance K220222 for IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4, Substantially Equivalent on 2022-04-26. Applicant: Shenzhen Yuwei Electronic Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Yuwei Electronic Technology 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- K262524 — Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.