BEUDAMED
    Product Code: OLP FDA class 2 21 CFR 878.4810

    Over-The-Counter Powered Light Based Laser For Acne

    General, Plastic Surgery

    The Over-The-Counter Powered Light Based Laser For Acne (product code OLP) is a Class 2 device regulated under 21 CFR 878.4810 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is intended for over-the-counter use to treat patients with mild to moderate acne vulgaris by emitting energy in both the red and blue regions of the light spectrum. The device is not an implant or life-sustaining, and is reviewed by the General, Plastic Surgery panel.

    View on FDA
    510(k)s
    51
    FEI Numbers
    109
    Registration Numbers
    109
    Unique Applicants
    43
    Years Active
    17

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    Basic Information

    Product Code
    OLP
    Device Class
    FDA class 2
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 51 510(k) clearances via K numbers.

    K Number Device Name
    K253878 LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
    K251843 Erchonia EVRL
    K242068 LED Light Therapy Mask (RT01)
    K243555 LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
    K232656 BLU TOTALE (Model: ENEOB852)
    K230490 PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
    K230720 LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
    K213056 LED Facial Mask
    K220729 The Luminance RED Acne Device
    K213039 Micro-current facial cold and hot service (model: TPML-100)
    K210545 Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
    K214103 Shani Darden LED light therapy mask
    K210968 reVive Light Therapy Essentials
    K213184 MZ Skin LightMAX Supercharged LED Mask 2.0
    K203214 DemarkQ WOW, DemarkQ POP
    K203271 Aduro light therapy Handheld
    K210948 Omnilux CLEAR
    K202055 Looper (Model: ZX-579S)
    K192295 PDT-FACE
    K183708 Poly Clear
    K183118 dpl SpotLite
    K180888 LYFT
    K180900 LED Light Therapy Device
    K180847 Neutrogena Light Therapy Acne Mask+
    K180447 reVive Light Therapy LED Cleansing System
    K172555 SAPPHIRE, ELEVARE SAPPHIRE
    K161434 Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
    K170111 Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
    K170260 BC-001+ Acne Purifier
    K162098 LED Phototherapy Device
    K162371 Pulsaderm ACE-All Blue
    K162450 ESPADA Acne-Clearing Blue Light Pen
    K161941 Pulsaderm Acne Device
    K160691 Acne Light Therapy Wand
    K160821 Tria Sapphire
    K153081 Clear Bi-Light
    K152889 SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
    K150370 Nutra Light Advanced
    K142246 LightStim for Acne/ LightStim for Acne Mini
    K132833 ULTRA RENEW PLUS
    K132838 NUTRA LIGHT BLUE
    K131461 LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
    K123999 ILLUMASK ACNE LIGHT THERAPY MASK
    K124042 TANDA MINI SKINCARE SYSTEM
    K121435 SILKN BLUE
    K111937 CLEARFLASH AC2100 COSMETIC SYSTEM
    K111286 QUASAR CALYPSO
    K102477 NO!NO! SKIN
    K093963 QUASAR BLUE LIGHT THERAPY SYSTEM
    K090744 CLARO
    K081307 OMNILUX CLEAR-U

    FEI Numbers

    This FDA classification entry is associated with 109 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 109 registration numbers. Click on an entry to view related FDA registrations.