Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)— 510(k) K242755

Substantially Equivalent

Gigaalaser Company , Ltd.

FDA 510(k) clearance K242755 for Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B), Substantially Equivalent on 2025-05-19. Applicant: Gigaalaser Company , Ltd..

Clearance details

Applicant: Gigaalaser Company , Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2024-09-12
Decision date: 2025-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.