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Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)

Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

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Company

Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.
China (CN)

Product code

OHT
21 CFR 878.4810

Predicate devices

3
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K241120
Device name
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
Company
Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-04-23
Decision date
2024-06-24
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyFace
Primary application
Body
Classification source
AI classified

Indications for Use

Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Intended Use

Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Device Description

Intense pulsed light therapy apparatus is an over-the-counter, home-use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes 12 models (Model: FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S), the model name with an 'S' indicates that the model has a cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and the device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses.

Summary parsed at:2026-06-11 04:46:12 UTC

Predicate devices

3

K241120 references 3 predicate/reference devices

Cited as predicate

1
  • K252234

    IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)

    Shenzhen Qiaochengli Technology Co., Ltd.

1 submission cite K241120 as a predicate