Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Magma Spark device is indicated for use in aesthetic and cosmetic applications in dermatology. Magma Spark device with ALD or LLD diode laser applicators is indicated for hair removal, permanent hair reduction in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB). (*Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completion of treatment regime)
Magma Spark device is indicated for use in aesthetic and cosmetic applications in dermatology. Magma Spark device with ALD or LLD diode laser applicators is indicated for hair removal, permanent hair reduction in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB).
The Magma Spark device is a computerized multi-application platform intended for non-invasive aesthetic applications utilizing laser optical power. Magma Spark is a relatively small tabletop device that is provided with a melanin meter and two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength. The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including an LCD display and touch screen module. The operator of Magma Spark chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device.
Summary parsed at:2026-06-01 06:07:02 UTC
Magma System
K162781 references 1 predicate/reference device
No later 510(k)s cite this device yet
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