Canadian Pioneer Medical Technology Corporation
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type 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.
The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type 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.
The proposed device is intended for hair removal. The device includes three models of handpieces for clearance in this submission. The differences between models are their spot sizes and density. The operation principle is that melanin could absorb the energy from the laser, which would result in temperature rapid increase, to destroy surrounding hair follicles, and finally remove hair. The device features a Class IV laser with a light delivery system of 808 nm. The spot sizes are 12×12mm, 12×20mm, and 15×27mm. The fluence ranges from 1~120J/cm2 at spot size 12×12mm, 1~70 J/cm2 at spot size 12×20mm, and 1~40 J/cm2 at spot size 15×27mm. The frequency is 1-10Hz, and the pulse duration is 10-300ms. The power supply is 100-240V AC, 50/60Hz. Patient contact materials include sapphire in the handpiece and handpiece tip (stainless steel).
Summary parsed at:2026-06-01 05:43:55 UTC
Laser Treatment System, Model: NYX and Grace
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