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510(k) Data Aggregation
K Number
K143003Device Name
iPulse Smooth Skin Gold Hair Removal System
Manufacturer
Ipulse Limited
Date Cleared
2015-06-18
(241 days)
Product Code
OHT, GEX, ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Ipulse Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
The iPulse SmoothSkin Hair Removal System is an intense pulsed light (IPL) system consisting of:
Handset - contained within the handset is the Capacitor, Capacitor Charger, Control electronics, Optics (Lamp, Filter, Reflector, Light Pipe), Trigger mechanism and Skin Tone / proximity Sensors (STS);
External Power Supply - used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a lower DC value, typically 24V. This power supply unit is an "off-the-shelf" component which meets all the relevant electrical safety standards.
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