Manufacturer
Beijing Adss Development Co., Ltd.Diode Laser Therapy System
Beijing Adss Development Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
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
Predicate devices
2Diode Laser Therapy Systems
The Alma Soprano Titanium
K231896 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K231896 as a predicate
