BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    StarWalker

    DI: 03830054237742 · Model: M031-3A/2 PICO Pro · FOTONA d.o.o.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    StarWalker
    Primary DI
    03830054237742
    Version / Model
    M031-3A/2 PICO Pro
    Company Name
    FOTONA d.o.o.
    Labeler DUNS
    644720625
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-20
    Public Version
    1
    Public Version Date
    2025-10-28
    Public Version Status
    New
    Public Device Record Key
    5d3c9ed0-4df5-49b6-ba5d-562a3fef6cdb

    Device Description

    The device is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd:YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or a 650 nm wavelength, correspondingly. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    36150 General/multiple surgical frequency-doubled solid-state laser system
    47877 Dermatological frequency-doubled solid-state laser system

    Identifiers

    Type ID
    Primary 03830054237742

    Premarket Submissions

    Submission Number Supplement Number
    K202172 000

    Storage Conditions

    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    50 – 106 KiloPascal
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 75 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 25 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    0 – 50 Degrees Celsius