Manufacturer
Shenzhen Leaflife Technology Co., Ltd.LED Therapy Device (Planar LED/Planar LED mini)
Shenzhen Leaflife Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K220103
- Device name
- LED Therapy Device (Planar LED/Planar LED mini)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-01-12
- Decision date
- 2022-04-12
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The LED Therapy Device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is 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
The LED Therapy Device is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is 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
The LED Therapy Device is a surgical device intended for use in dermatologic and general surgical procedures. It utilizes a diode LED as a light source (780-850 nm). The LED light power is delivered to the treatment area via a LED hand piece. The emission LED is activated by a foot switch and a hand piece. The proposed LED Therapy Device is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.
Summary parsed at:2026-06-01 05:39:38 UTC
Predicate devices
3—
—
Not ingested
IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
Laser Therapy Device
K220103 references 3 predicate/reference devices
Cited as predicate
1Planar LED mate
1 submission cite K220103 as a predicate
