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510(k) Data Aggregation
K Number
K172791Device Name
Lumilisse IPL Hair Remover
Manufacturer
Conair Corporation
Date Cleared
2018-01-18
(125 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Conair Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.
Device Description
The Lumilisse IPL Hair Remover (Figure 11.1) is a hair-removal device that eliminates unwanted hair from the body (legs and arms), and from more sensitive areas (underarms, bikini line, lower half of the face - below the cheekbones) using intense pulse light technology.
The Lumilisse IPL Hair Remover is an Intense Pulsed Light (IPL) system consisting of:
- . Handset - contained within the handset is the High Voltage Capacitor, Capacitor Charger, Control Electronics and Firmware, Quartz Light Tube, Cooling System, Skin Tone and Skin Contact Sensors and the firmware for operation and safety.
- External Power Supply – used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a much lower DC value. This power supply unit is an "off-theshelf" component which meets all the relevant electrical safety standards.
- Skin Color Sensor System - For effective and safe treatment, the Lumilisse IPL Hair Remover is equipped with the Skin Sensor System, a skin color detection system that automatically regulates the light intensity applied to the skin.
- . Levels of Intensity - The Lumilisse IPL Hair Remover features 5 levels of intensity, running from the lowest (level 1) to the highest (level of intensity indicates the intensity of the pulsed light applied to the skin when using the Lumilisse Hair Remover.
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