Gigaalaser Company Ltd.

Gigaalaser Company Ltd. specializes in laser-based medical devices. Their portfolio includes dental diode laser systems, primarily used for soft tissue procedures in dentistry, as well as non-wearable infrared phototherapy units designed for musculoskeletal and nail treatments. These devices are developed for clinical and aesthetic applications, covering areas like dental surgery, pain management, and cosmetic nail care.

Gigaalaser Company Ltd. is based in the United States, meaning its devices must comply with US regulatory requirements. Since their products are classified as Class II medical devices, they are subject to the FDA’s regulatory pathways, including 510(k) premarket notifications and UDI (Unique Device Identification) registration. The company’s submissions appear in the FDA’s public registries, ensuring transparency and adherence to US medical device regulations.

Gigaalaser Company Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) submissions demonstrate that each device has been evaluated for substantial equivalence to a legally marketed predicate, while the UDI system ensures traceability and identification of devices throughout their lifecycle. These registries are key for tracking compliance with US medical device regulations.

Gigaalaser Company Ltd.’s devices are classified as Class II medical devices in the US. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require premarket notifications (510(k)) to demonstrate compliance with FDA requirements before commercial distribution.