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

    UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)

    K Number: K242908 · Decision Dec 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    1
    Review Days
    86

    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
    UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
    K Number
    K242908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Sigma High-Tech Co., Ltd.
    Date Received
    September 24, 2024
    Decision Date
    December 19, 2024
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

    Similar 510(k) Clearances

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

    Phototherapy System (DUV-COMBO)

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

    Klär Lite (RCW-KL1000)

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

    Ultraviolet Phototherapy Device

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

    308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

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

    308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)

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

    DT Controlled Phototherapy Equipment

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