Manufacturer
Shenzhen Leaflife Technology Co., Ltd.Planar LED mate
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
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K230362
- Device name
- Planar LED mate
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-02-10
- Decision date
- 2023-09-11
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- BodyFace
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.
Intended Use
The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair.
Device Description
The Planar LED mate is a prescription-use only device intended for removal of unwanted body and/or facial hair. It utilizes a diode LED as a light source (780-850 nm). 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 emission activation is by finger switch. The device contains a capacitive sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light. The device is for single-person use only. The proposed Planar LED mate 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. The device has 5 level Output Intensity.
Summary parsed at:2026-06-11 04:39:10 UTC
Predicate devices
4—
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Not ingested
LED Therapy Device (Planar LED/Planar LED mini)
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Not ingested
IPL Hair Removal Device
K230362 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K230362 as a predicate
