Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Gigaalaser Company , Ltd.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories3
Latest FDA decision2025-05-19
TypeNumberDevice NameCodeDateActions
510(k) K242755 Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)ILY2025-05-19 View
510(k) K250018 Medical Diode Laser Systems (THEIA808)GEX2025-04-01 View
510(k) K241791 Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)GEX2025-03-19 View
510(k) K230047 Medical Diode Laser SystemsNVK2024-03-04 View