Planar LED mate

Shenzhen Leaflife Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

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Product code

OHT
21 CFR 878.4810

Predicate devices

4

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

K230362 references 4 predicate/reference devices

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