Diode Laser Hair Removal System

Beijing Winkonlaser Technology Limited

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

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K241860
Device name
Diode Laser Hair Removal System
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-06-27
Decision date
2024-09-25
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Diode Laser Hair Removal System 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 Diode Laser Hair Removal System 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 Diode Laser Hair Removal System utilizes an 808nm diode laser using selective light absorption, preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, with minimal energy transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around the hair follicle, thereby reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect it. The device adopts a Gold standard 808nm semi-conductor laser, based on the principle of selective photothermolysis, where the specific wavelength penetrates the epidermis into the dermis, and the optical energy is absorbed and translated into heat energy that restrains hair follicle tissues, producing a photothermal effect. It effectively targets hair follicles rich in melanin while surrounding tissues absorb less or no energy, achieving hair removal without harming adjacent tissues and providing a virtually pain-free experience.

Summary parsed at:2026-06-01 05:28:50 UTC

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