United StatesFDA 510(k) K241791Traditional 510(k), cleared 19 March 2025, substantially equivalent. Product code GEX, Class II; 21 CFR 878.4810. VELAS Pro-30B15D is one of the seven models named in the clearance.
Quality systemISO 13485Medical device quality management system, independently audited. Certificate and scope of registration supplied on request for your market.
Audit programMDSAPAudited under the Medical Device Single Audit Program, recognized by the United States, Canada, Brazil, Australia and Japan.
European UnionCE markBoth models are CE marked. The declaration of conformity and labeling are issued by the manufacturer that built the device.
What the FDA clearance does — and does not — cover. K241791 clears seven diode laser models under product code GEX (21 CFR 878.4810, Class II). The model cleared at 980nm or 1470nm is VELAS Pro-30B15D.
Its cleared indications are surgical applications requiring vaporization, incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue in conjunction with endoscopic equipment; endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux; and laser-assisted lipolysis.
Aesthetic skin tightening or lifting is not among the cleared indications for this device. Confirm the applicable clearances and permitted indications for your market with our export desk before you publish any local claim.