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PERSONAL MEDICAL DEVICEBTFDA 510(k)

CLEANE

Blue light and heat,
a 2 min 30 sec routine

CLEANE with its protective cap removed, and the cap
Features

Heat and light
in a compact device

Using CLEANE with the heating tip on the cheek
Heat

47–49℃ heating tip

Output temperature 47.2–49.4℃. Reaches the set temperature within 150 seconds of power-on.

Blue LED

Blue LED

The blue LED around the heating tip lights up together with the heat.

Timer

2 min 30 sec auto timer

Beeps every 3 seconds and stops on its own after 2 min 30 sec.

Portable

30g · rechargeable

A small cylindrical body with a protective cap. Fits in a pocket or pouch.

Routine

One button,
four steps

The lamp color shows the status. Tap ‘Show steps’ below to quickly follow the actual operating sequence.

CLEANE device with the protective cap removed
0:00
  1. 01Power onA short press of the power button turns on the green lamp and the heating tip begins to warm up.
  2. 02ReadyWhen the set temperature is reached, a beep sounds and the green and blue lamps blink alternately.
  3. 03Use for 2 min 30 secPress the button again and place the heating tip on the target area. A beep sounds every 3 seconds.
  4. 04Auto stop · power offWhen time is up, it stops with a beep. Press the power button for 2 seconds to turn it off.

※ The time on screen is a sped-up example. Actual use time is 2 min 30 sec.

Before use

Do not use
in these cases

This is a medical device. Be sure to read the precautions in the user manual before use.

Blackheads · whiteheads, severe nodular · cystic acne
Sensitive areas such as around the eyes and lips, or sensitive skin that may be damaged by heat
Other skin conditions, infected skin, boils, wounds, insect bites
More than 3 uses a day, or less than 4 hours since the previous use
Repeated use on the same area more than 3 times
Use by children alone — adult supervision is required

※ If you are using medication that makes the skin peel or more sensitive to heat, consult a doctor before use. If pain or an adverse reaction occurs, stop use and consult a professional.

CLEANE device with the protective cap removed, and the cap
In the box

In the box

  • DeviceHeating tip · blue LED
  • Protective cap
  • Charging cableMicro 5-pin USB
  • User manual

※ Charge for at least 1 hour before first use. The device does not operate while charging.

Specification

Product specifications · approval

Product name · model nameMedical heating device (A16150) · CLEANE
Intended useA device that applies a constant level of heat to the body for use in treating acne
MFDS product approval No. (Korea)No. 08-766
International certificationsUS FDA 510(k) · EU CE
Output temperature47.2–49.4 ℃ · heats up within 150 sec
Use time2 min 30 sec (auto stop)
BatteryDC 3.7V · 250mAh · power consumption 3VA
Charger input100 ~ 240V, 50/60Hz
Weight30 g
ManufacturerMEDICON Co., Ltd. · Republic of Korea
FAQ

Frequently asked questions

QHow many times a day can I use it?
Use it up to 3 times a day, with at least 4 hours between uses. Use no more than 3 times on the same area.
QWhat happens after 2 min 30 sec?
It stops with a beep and the lamps blink alternately. Press the button again within 60 seconds to continue on another area right away; otherwise the power turns off automatically.
QHow do I charge it?
Charge via Micro 5-pin USB. The green lamp is on while charging; when complete, the blue lamp turns on and a beep sounds.
QHow should I care for it after use?
Wipe the heating tip with a clean cloth or alcohol swab, put on the protective cap, and store in a dry place.
Medical device advertising notice

This product is a medical device. Be sure to check the precautions and directions for use before use. MFDS product approval No. 08-766 (Korea) · Intended use: a device that applies a constant level of heat to the body for use in treating acne.

CLEANEPersonal medical heating device · MFDS product approval No. 08-766 (Korea)
User manualView at official store