Diode Laser Therapy System

Beijing Adss Development Co., Ltd.

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

Predicate devices

2

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0

Device details

FDA 510(k) registration fields

K number
K231896
Device name
Diode Laser Therapy System
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-06-28
Decision date
2024-02-20
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalVascular treatment
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for the NIR Modules are: • Elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, • The temporary relief of minor joint pain associated with arthritis, • The temporary increase in local circulation where applied, and • The relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Intended Use

The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Device Description

The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base. The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction. The Diode Laser Therapy System (Model: FG2000-D+/FG2000-D+Pro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.

Summary parsed at:2026-06-01 05:26:22 UTC

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