Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-IV. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. Permanent hair reduction is defined as the 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.
The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-IV. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. Permanent hair reduction is defined as the 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.
The ELux810 Laser is a diode laser of 808nm system. This device is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to use in various treatments by effecting to skin by laser beam of 808nm generated from laser diode. Diode laser of CW system is able to transfer stable and uniform pulses to skin, therefore medical doctor can treat patient safely and effectively using this equipment.
Summary parsed at:2026-06-01 06:10:16 UTC
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K141986 references 1 predicate/reference device
No later 510(k)s cite this device yet
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