Nira Innovations Incorporated

Nira Innovations Incorporated specializes in dermatological laser beam guiding handpieces. These devices are specifically designed to assist in precision skin treatments, ensuring accurate laser application during dermatological procedures. Examples include the NIRA PRO, NIRA Pro+, and NIRA Precision Laser, all tailored for controlled laser use in dermatology.

Nira Innovations Incorporated is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in markets like the U.S., where its devices may be subject to FDA oversight.

Nira Innovations Incorporated’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II devices, which include the company’s dermatological laser handpieces, by assigning them a standardized identifier for tracking and compliance purposes.

Nira Innovations Incorporated’s dermatological laser beam guiding handpieces fall under Class II medical device classification. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and the level of regulatory control required to ensure safety and effectiveness. Class II devices typically require special controls beyond general controls to mitigate moderate risks.