Clearance Summary
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) received FDA 510(k) clearance under submission number K242755, sponsored by Gigaalaser Company , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2025-05-19.
- Submission: K242755
- Applicant / Sponsor: Gigaalaser Company , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2025-05-19
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.