Manufacturer
Risu Medical Technology Co., Ltd.Diode laser device (RF3120-BI)
Risu Medical Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K251329
- Device name
- Diode laser device (RF3120-BI)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-30
- Decision date
- 2025-06-27
- 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 Diode laser device is intended for use in dermatology procedures requiring coagulation. The indications for use for the Trio-Wavelength Handpiece include: The Fast Hair Removal (FHR) Mode is intended for temporary hair reduction. The HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions. The 810nm wavelength handpiece is 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. (HR, and FHR Modes).
Intended Use
The Diode laser device is intended for use in dermatology procedures requiring coagulation. The indications for use for the Trio-Wavelength Handpiece include: The Fast Hair Removal (FHR) Mode is intended for temporary hair reduction. The HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions. The 810nm wavelength handpiece is 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.
Summary parsed at:2026-06-01 05:23:07 UTC
Predicate devices
0No predicate K numbers were extracted
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Cited as predicate
1Diode Laser Therapy Systems (WLA-02)
1 submission cite K251329 as a predicate