IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)

Dongguan Lide Electric Appliance Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

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Product code

OHT
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K253304
Device name
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-09-29
Decision date
2025-11-25
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
FaceBodyOther
Primary application
Body
Classification source
AI classified

Indications for Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device 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. Applicable skin types are Fitzpatrick Skin Types I-V.

Intended Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. The device 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.

Device Description

IPL Hair Removal Device is an over-the-counter, home-use device for unwanted hair removal by using Intense Pulsed Light (IPL). It has been designed in eight models with the same IPL technology for hair removal: KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain. The device is powered by an external power adapter and its IPL emission activation is by finger switch or auto flash mode. The IPL Hair Removal Device has an irreplaceable flash window and can cover an area of 3.0cm2 for models KA-10, KA-11, KA-11C, KA-11D, and 3.3cm2 for models KA-18, KA-20, KA-21, KA-21C, suitable for multiple hair removal areas such as upper lip, armpit, bikini line, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact; if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. Additionally, the IPL Hair Removal Device has a sapphire cooling function (Model: KA-18, KA-20, KA-21) and ice cooling function (Model: KA-10, KA-11, KA-11C, KA-11D), activated throughout the hair removal process to cool down the treatment area's temperature and provide a better user experience.

Summary parsed at:2026-06-11 04:32:48 UTC

Predicate devices

3

K253304 references 3 predicate/reference devices

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