Manufacturer
Shenzhen Leaflife Technology Co., Ltd.Leaf Smooth
Shenzhen Leaflife Technology 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
- K212697
- Device name
- Leaf Smooth
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-08-25
- Decision date
- 2021-11-19
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- BodyFace
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The Leaf Smooth is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Intended Use
The Leaf Smooth is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Description
The Leaf Smooth (LH-LIPLB) is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. 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 contains a Xenon Arc Flashlamp, capacitive sensor to detect appropriate skin contact and a skin sensor to detect appropriate skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only. The Leaf Smooth has 6 levels output intensity.
Summary parsed at:2026-06-11 04:28:59 UTC
Predicate devices
3—
—
Not ingested
IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
K212697 references 3 predicate/reference devices
Cited as predicate
2IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
Light Based Hair Removal Device
2 submissions cite K212697 as a predicate