BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Candela Corporation

    Reg #: 3016496662 · FEI: 3016496662 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    Candela Corporation
    Registration Number
    3016496662
    FEI Number
    3016496662
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    251 Locke Drive
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232977

    Owner / Operator

    Firm Name
    Candela Corporation
    Operator Number
    1218402
    Address
    251 Locke Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Greg Wallender

    Products

    Device Name Product Code
    Fat Reducing Low Level Laser OLI
    Light Based Over The Counter Wrinkle Reduction OHS
    Lamp, Infrared, Therapeutic Heating ILY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Over-The-Counter Powered Light Based Laser For Acne OLP
    Massager, Vacuum, Light Induced Heating NUV
    Powered Laser Surgical Instrument GEX
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis PDZ
    Brush, Dermabrasion, Powered GFE

    Proprietary Names

    Celluma Pro C3 eTwo Velashape, Velashape II GentleYAG LE GentleYAG GentleYag Pro U Vbeam Pro Vbeam Prima Pro Vbeam Prima Vbeam Perfecta Nordlys, Nordlys Mini Picoway Laser System Nordlys (Ellipse Nordlys); Sirius; IPL; Nd:YAG Profound GentleMax Pro GentleMax Pro, GentleLase Pro U, GentleYag Pro U Gentle Pro Series Alex Trivantage Candela Q-Switched Alexandrite Laser AlexTrivantage GentleMax Pro Plus Glace GentleLase Pro GentleLase Pro LE GentleTouch The Gentle Family, Gentle Pro Series CO2RE, CO2RE Intima Profound Matrix Matrix Elos Plus Dynamic Cooling

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility