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510(k) Data Aggregation
K Number
K073317Device Name
STARLIGHT, MODEL PD9012
Manufacturer
Date Cleared
2008-09-03
(282 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
F.P. RUBINSTEIN Y CIA S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
STARLIGHT® is a light-based system intended for the removal of unwanted hair (permanent hair reduction*) and the treatment of benign cutaneous, vascular and pigmentary lesions in skin phototypes I to V of the Fitzpatrick Table.
*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
Device Description
STARLIGHT® is a light-based system that delivers Intense Pulsed Light in the region of 530 to 1200 nanometers of the Electromagnetic Spectrum. The system has been designed to be compact and self-contained, comprising:
-A central module
-An LCD and soft-touch keyboard interface
-Two application handpieces housing a flash lamp, a light conducting glass w/filter and two shooting buttons
-An integrated Hydraulic Cooling System
The system's electronics and user interface are controlled by a microcontroller.
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