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Diode laser hair removal new 510K approval 2026 using 808nm wavelength
The Diode Laser System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type IVI), 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.
808 nm
Fluence 1-120J/ cm2
Irradiance 0.7-347.8 W/cm2
Frequency 0.5-15Hz
Pulse Duration 5-400ms
IPL new 510K (2026) approval of removal machine
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. 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 regimen.
430-1200nm,
530-1200nm,
640-1200nm,
Optional: 480-1200nm,560-1200nm, 590-1200nm,690-1200nm, 750 -1200nm