Lumilisse IPL Hair Remover

Conair Corporation

Country / region:United States (US)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

View Summary PDF

Company

United States (US)

Product code

OHT
21 CFR 878.4810

Predicate devices

3

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K172791
Device name
Lumilisse IPL Hair Remover
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

3

K172791 references 3 predicate/reference devices

Cited as predicate

2

2 submissions cite K172791 as a predicate