BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K

    K Number: K221569 · Decision Jun 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    91
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    30

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
    K Number
    K221569
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Fansizhe Science and Technology Co., Ltd.
    Date Received
    May 31, 2022
    Decision Date
    June 30, 2022
    Product Code
    OHT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OHT Light Based Over-The-Counter Hair Removal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OHT), ordered by most recent decision date.

    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    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)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    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)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IPL Hair Removal Device (Models: T31A, T32A)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Shenzhen Fansizhe Science and Technology Co., Ltd.

    K Number Device Name
    K253881 Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
    K251173 Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
    K223928 Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
    K212881 Intense Pulsed Light (IPL) System