Nanjing Bestview Laser S&T Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Deluxlase is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Deluxlase is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Thulium Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a hand piece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The Thulium Laser System is equipped with a 650 nm aiming beam.
Summary parsed at:2026-06-01 05:23:37 UTC
Lavieen
K251919 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K251919 as a predicate
