# Gigaalaser Company, Ltd.

- Location (FDA's records): Wuhan, CN
- FDA decisions: 4 (2024–2025): 4 510(k) clearances
- Product codes: GEX (2), NVK (1), ILY (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aspen Laser Systems, LLC: 2 (https://510kreport.com/company/aspen-laser-systems)
- Shandong Huamei Technology Co., Ltd.: 1 (https://510kreport.com/company/shandong-huamei-technology)
- Squalus Med, Ltd.: 1 (https://510kreport.com/company/squalus-med)
- Fotona D.O.O.: 1 (https://510kreport.com/company/fotona-doo)
- Alma, Inc.: 1 (https://510kreport.com/company/alma)
- Wuhan Pioon Technology Co., Ltd.: 1 (https://510kreport.com/company/wuhan-pioon-technology)
- Guilin Woodpecker Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/guilin-woodpecker-medical-instrument)
- Technological Medical Advancments, Inc. (Tma): 1 (https://510kreport.com/company/technological-medical-advancments-tma)

## Firms that cite its devices most
- Wuhan PHOMED Technology Company, Ltd.: 1 (https://510kreport.com/company/wuhan-phomed-technology)
- Wuhan Pioon Technology Co., Ltd.: 1 (https://510kreport.com/company/wuhan-pioon-technology)

## Its most-cited devices
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (2025), cited by 1
- K230047: Medical Diode Laser Systems (2024), cited by 1
- K242755: Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (2025), cited by 1

## Recent decisions
- K242755: Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (May 19, 2025)
- K250018: Medical Diode Laser Systems (THEIA808) (Apr 1, 2025)
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (Mar 19, 2025)
- K230047: Medical Diode Laser Systems (Mar 4, 2024)

Source page: https://510kreport.com/company/gigaalaser