Manufacturer
Conair CorporationLumilisse IPL Hair Remover
Country / Region:United States (US)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K172791
- Device name
- Lumilisse IPL Hair Remover
- Company
- Conair Corporation
- Country / Region
- United States(US)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-09-15
- Decision date
- 2018-01-18
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair. Flash N Go is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as long-term, stable reduction in hair counts following a treatment regime. The mē is an over-the-counter device intended for the removal of unwanted hair. Mē is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months. 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.
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 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-the-shelf' 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 5). The level of intensity indicates the intensity of the pulsed light applied to the skin when using the Lumilisse Hair Remover. The Lumilisse Hair Remover can be used by men and women aged 21 and older.
Summary parsed at:2026-06-11 04:23:05 UTC
Predicate devices
3Cited as predicate
2Beurer IPL 8500 device/ IPL VelvetSkin Pro
Aimanfun Lumea Comfort
2 submissions cite K172791 as a predicate
