Search Results
Found 1 results
510(k) Data Aggregation
K Number
K200736Device Name
Stardust Med
Manufacturer
Date Cleared
2020-06-26
(95 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
I.T.S. Group S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery.
STARDUST MED is indicated for hair removal and permanent hair reduction.
Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime
Device Description
STARDUST MED is a laser emitting device that is operated with handpiece in contact with the skin.
STARSDUST MED comprises a main console unit and a handpiece that is triggered by means of footswitch or a finger switch.
A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface.
The main console can be connected to the following handpiece:
- -808 nm Laser diode.
Ask a Question
Ask a specific question about this device
Page 1 of 1