Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Lustre PRO light system is indicated for the treatment of mild to moderate acne.
The Lustre PRO light system is indicated for the treatment of mild to moderate acne.
The Lustre PRO light system is a small portable non-invasive device, comprising of a rechargeable controller and therapy heads containing light emitting diodes, emitting blue light at a peak wavelength of 415nm, and a Full Width Half Maximum (FWHM) of 15nm. The therapy heads are designed to be attached to the skin at the site of the acne using a disposable polyethylene film impregnated with a medical-grade adhesive. The controller comprises of an LCD graphical user interface, 3 control buttons, a coaxial connector and 3 mini USB connectors. The controller switches the therapy heads on and off and includes a programmable timer, allowing modification of treatment time and indicators for battery level, therapy head status and treatment time remaining. The device contains sensors which monitor the therapy heads and emit audible and visible alarms relating to overheating and disconnection of the therapy heads.
Summary parsed at:2026-06-01 06:05:00 UTC
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K143713 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K143713 as a predicate
