Manufacturer
Ivylaser (Beijing) Technology Co.,LtdDiode laser system (Night Universe; Predator)
Ivylaser (Beijing) Technology 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
- K250206
- Device name
- Diode laser system (Night Universe; Predator)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-24
- Decision date
- 2025-04-24
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
Diode laser system is used for hair removal, HR mode is for professional hair removal, and FHR is for rapid hair removal. The indications for use for the 810nm Diode Laser Module include: The HR mode and FHR mode are intended for hair removal and permanent hair reduction. Use on all skin types (Fitzpatrick 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
Diode laser system is used for hair removal, HR mode is for professional hair removal, and FHR is for rapid hair removal. The indications for use for the 810nm Diode Laser Module include: The HR mode and FHR mode are intended for hair removal and permanent hair reduction. Use on all skin types (Fitzpatrick 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 device operates at a wavelength of 810nm, with energy density for HR mode ranging from 2J/cm to 60J/cm and for FHR mode from 2J/cm to 10J/cm. It features two operation models: HR and FHR, with a spot size of 2 cm². The laser type is Diode Laser, with a pulse width of 5ms to 200ms, and frequency for HR mode is 1-3Hz and for FHR mode is 5-10Hz. The cooling methods include water and air. The device weights 60Kg and 33Kg, with sizes for Night Universe at 350mm x 450mm x 1000mm and for Predator at 500mm x 600mm x 500mm. Differences in size and weight do not affect the safety and effectiveness of the product.
Summary parsed at:2026-06-01 05:22:19 UTC
Predicate devices
1The Alma Soprano Titanium
K250206 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
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