Manufacturer
Shenzhen Koli Technology Co.,LtdIPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
Shenzhen Koli Technology 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
- K232183
- Device name
- IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-07-24
- Decision date
- 2023-09-22
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Hair Removal Device is indicated for the removal of unwanted 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.
Intended Use
IPL Hair Removal Device is indicated for the removal of unwanted 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 (Models:T1, T2, T3, T7, T10) is an over-the-counter, home-use and single-person-use device for hair reduction by using 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 only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas. There are four function modes including skin, face, body and bikini for T1 and T7, but only body mode for T3, and five modes including skin, face, underarm, body and bikini for T2 and T10. There are five levels for each mode. The device contains a skin sensor to detect appropriate skin contact; if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. IPL Hair Removal Device, models: T1, T2, T3, T7, T10 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, dimension, weight, number of keys and function modes, spot size and energy density. The five models are in two colors, one set is in white and the other set is in green.
Summary parsed at:2026-06-11 04:41:45 UTC
Predicate devices
2IPL Home Use Hair Removal Device
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
K232183 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K232183 as a predicate
