Delfin Technologies, Ltd.

Delfin Technologies, Ltd. specializes in medical devices designed for specific diagnostic purposes. Their portfolio includes the MoistureMeterD Compact, a handheld device used to measure moisture levels in tissues, and the LymphScanner, a tool for evaluating lymphatic function. These devices are developed to assist healthcare professionals in assessing physiological conditions that require precise, non-invasive measurements.

Delfin Technologies, Ltd. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class II classification—requiring performance standards or special controls—they must comply with FDA requirements for clearance via the 510(k) pathway, demonstrating substantial equivalence to legally marketed predicate devices before entering the market.

Delfin Technologies, Ltd.’s devices are listed in the FDA’s 510(k) clearance registry because their products are classified as Class II, necessitating pre-market notification to the FDA. This registry tracks devices that have undergone the 510(k) process, ensuring transparency about their regulatory status and compliance with FDA requirements before commercial distribution.

Delfin Technologies, Ltd.’s devices are classified as Class II under FDA regulations, indicating they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification means the company must follow specific FDA guidelines, including performance standards or post-market surveillance, to demonstrate their devices meet regulatory requirements before they can be legally marketed.