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

    UVBIOTEK MODELS 3200B AND 4000B

    K Number: K051330 · Decision Nov 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    1
    Review Days
    182

    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
    UVBIOTEK MODELS 3200B AND 4000B
    K Number
    K051330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtek Lighting Corporation
    Date Received
    May 20, 2005
    Decision Date
    November 18, 2005
    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

    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
    View all