FDA 510(k) Applications Submitted by Gigaalaser Company Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K250018 01/03/2025 Medical Diode Laser Systems (THEIA808) Gigaalaser Company Ltd.
K230047 01/06/2023 Medical Diode Laser Systems Gigaalaser Company Ltd.
K241791 06/21/2024 Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) Gigaalaser Company Ltd.
K242755 09/12/2024 Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) Gigaalaser Company Ltd.


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