Manufacturer
Alovea Healthcare Co. , Ltd.IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
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
- K252618
- Device name
- IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
- Company
- Alovea Healthcare Co. , Ltd.
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-08-19
- Decision date
- 2025-11-14
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyFace
- 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.
Intended Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair removing by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model I6 S1, I6 D1 and I6 M1. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain. Model I6 S1 adopts single pulse technology, I6 D1 adopts dual pulse technology, and I6 M1 can switch between single pulse and dual pulse. The device is only powered by the external power adapter and its IPL emission activation is by finger switch or auto flash mode. The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.3cm2 that is suitable for multiple hair removal areas, such as limbs, armpits, upper lip, back, chest, bikini area. 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. Besides, the IPL Hair Removal Device has the sapphire ice cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
Summary parsed at:2026-06-11 04:32:08 UTC
Predicate devices
3Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
IPL Hair Removal Device (BE965A, BE965B, BE965C)
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
K252618 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 K252618 as a predicate
