BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Tanning Lamp

    K Number: K221523 · Decision Feb 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    265

    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
    Tanning Lamp
    K Number
    K221523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unilam Co., Ltd.
    Date Received
    May 26, 2022
    Decision Date
    February 15, 2023
    Product Code
    LEJ
    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
    LEJ Booth, Sun Tan

    Similar 510(k) Clearances

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

    Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline

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

    KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

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

    Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound

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

    Ergoline Sunrise 7200 Hybrid Technology

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

    Ergoline Prestige 1600 Hybrid Performance

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

    ProSun sunlamp products, Luxura sunlamp products

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

    Other Clearances by Unilam Co., Ltd.

    K Number Device Name
    K143043 Tanning Lamp