IPL Hair Removal Device
Zhongshan Bisen Plastic Electronic Products Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K212314
- Device name
- IPL Hair Removal Device
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-07-23
- Decision date
- 2021-10-21
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBody
- 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
The IPL Hair Removal Device is a light-based device and an over-the-counter device which is expected to be sold directly to end users. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. 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. The device has two working modes, an automatic mode and a manual mode. Each mode has 5 levels of output energy. The device contains a Xenon lamp that emits pulses of light (a total of 350000 pulses over the device's lifetime) and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), it will cannot emit the treatment light pulses.
Summary parsed at:2026-06-11 04:28:46 UTC
Predicate devices
1IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
K212314 references 1 predicate/reference device
Cited as predicate
1Hand-held IPL device(JOVS Graphene Hair Removal Device)
1 submission cite K212314 as a predicate