BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPECTRA 724

    K Number: K854498 · Decision Nov 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    269
    Applicant Total
    5
    Review Days
    13

    Basic Information

    Device Name
    SPECTRA 724
    K Number
    K854498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    DAAVLIN CO.
    Date Received
    November 12, 1985
    Decision Date
    November 25, 1985
    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.

    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

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

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

    DT Controlled Phototherapy Equipment

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

    Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)

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

    Other Clearances by DAAVLIN CO.

    K Number Device Name
    K063621 3 SERIES PHOTOTHERAPY CABINET
    K930856 PSORALITE
    K828654 UVB CABINET OR GOEKERMAN CABINET, MODEL SPECTRA 305
    K827690 SPECTRA MINI, ULTRAVIOLET EMITTER FOR DERMATOLOGICAL USE