About This 510(k) Submission
K242755 is an FDA 510(k) clearance for the Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B), a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Gigaalaser Company , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on May 19, 2025, 249 days after receiving the submission on September 12, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.