BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Solta Medical, Inc.

    Reg #: 3011423170 · FEI: 3004106598 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    6
    Establishment Types
    5
    Classifications
    8

    Registration Details

    Registration Name
    Solta Medical, Inc.
    Registration Number
    3011423170
    FEI Number
    3004106598
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11720 N Creek Pkwy N, Suite 100
    City
    Bothell
    State
    WA
    ZIP
    98011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100874

    Owner / Operator

    Firm Name
    Solta Medical
    Operator Number
    9042311
    Address
    11720 North Creek Parkway N., Suite 100
    City
    Bothell
    State
    WA
    Postal Code
    98011
    Country
    US
    Correspondent
    Sophie XU

    Products

    Device Name Product Code
    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption OHV
    Powered Laser Surgical Instrument GEX
    System, Suction, Lipoplasty For Removal QPB
    Massager, Therapeutic, Electric ISA
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    System, Suction, Lipoplasty MUU
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    Liposonix System Model 1 PowerX Lipo System Clear+Brilliant TOUCH Fraxel re:store DUAL Laser System Permea Clear+Brilliant Laser System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility