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

    Intense Pulsed Light (IPL) System

    K Number: K212881 · Decision Apr 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    95
    Same Product Code
    141
    Applicant Total
    3
    Review Days
    213

    Basic Information

    Device Name
    Intense Pulsed Light (IPL) System
    K Number
    K212881
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Fansizhe Science And Technology Co., Ltd
    Date Received
    September 10, 2021
    Decision Date
    April 11, 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 (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)

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

    Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)

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

    IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)

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

    IPL400

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

    Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)

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

    IPL Hair Removal Device (KCA511/KCA516/KCA522)

    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
    K223928 Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
    K221569 Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K