Manufacturer
Dongguan Lide Electric Appliance Co., Ltd.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
Product code
OHT
21 CFR 878.4810
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
3IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
IPL Cooling Hair Removal Device
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
K253304 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K253304 as a predicate
