Medical Device Manufacturer · CN , Wuhan

Gigaalaser Company , Ltd.

4 submissions · 4 cleared · Since 2024
4
Total
4
Cleared
0
Denied

Gigaalaser Company , Ltd. — FDA 510(k) Submissions

Gigaalaser Company , Ltd. has submitted 4 FDA 510(k) premarket notifications since 2024, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Laser, Dental, Soft Tissue, Lamp, Infrared, Therapeutic Heating . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
K242755 · ILY Lamp, Infrared,... · General & Plastic Surgery
May 2025 249d
Medical Diode Laser Systems (THEIA808)
K250018 · GEX Powered Laser Surgical... · General & Plastic Surgery
Apr 2025 88d
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
K241791 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 2025 271d
Medical Diode Laser Systems
K230047 · NVK Laser, Dental, Soft Tissue · Dental
Mar 2024 423d
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All4 General & Plastic Surgery 3 Dental 1