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

    METEC HELARIUM LOUNGE & SKY UNITS

    K Number: K812225 · Decision Mar 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    3
    Review Days
    217

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    Basic Information

    Device Name
    METEC HELARIUM LOUNGE & SKY UNITS
    K Number
    K812225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Klafs Sunlight Corp.
    Date Received
    August 10, 1981
    Decision Date
    March 15, 1982
    Product Code
    FTC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    RA
    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

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    Other Clearances by Klafs Sunlight Corp.

    K Number Device Name
    K873430 FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12
    K812521 SUNTANNING DEVICE (SEPAR. FROM K812225)