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IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S

Zhongshan Qizhe Technology Co., Ltd.

Country / Region:China (CN)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

Summary PDF

Company

Zhongshan Qizhe Technology Co., Ltd.
China (CN)

Product code

OHT
21 CFR 878.4810

Predicate devices

3
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K231215
Device name
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
Company
Zhongshan Qizhe Technology Co., Ltd.
Country / Region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-04-28
Decision date
2023-06-26
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyOther
Primary application
Body
Classification source
AI classified

Indications for Use

The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.

Intended Use

The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.

Device Description

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S are a small over-the-counter device for the reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is powered by the external power adaptor or built-in battery and its IPL emission activation is by a switch or auto light emission. The device contains a Xenon arc flashlamp, one built-in battery, a capacitive sensor to detect appropriate skin contact, and a skin color sensor to detect the skin tone. The skin color sensor is fixed in the 'Skin color recognition Window' of the IPL Hair Removal device, and the device's skin color sensor automatically detects skin tone for your protection when the device is powered on. If your skin tone is not in the tone table suitable for treatment, the device must not be used. The capacitive sensor is assembled in the device probe of the IPL Hair Removal device; if the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. Based on the cooling technology, the IPL Hair Removal device has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation. The device can be powered on by a built-in battery or cable adaptor. The built-in lithium battery can be recharged. The IPL Hair Removal Device includes the main unit (including built-in battery), an adaptor, goggles, and a shaver. The device is intended to be used for adults aged over 18.

Summary parsed at:2026-06-11 04:39:57 UTC

Predicate devices

3

K231215 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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