Regulatory Information

Smart Vision Labs is certified to ISO 13485:2003 for Quality Management System – Medical Device Manufacturer. Our goal is to develop and manufacture safe and effective products and services, exceeding our customer’s expectations, under the guidelines of the ISO standards.

The SVOne device carries CE Marking certification, establishing freedom of sale throughout most of the European Union member states. This device is also listed as a Class 1 510(k) Exempt Medical Device, registered with the US FDA, and is considered safe and effective for patient (human) use. It has been manufactured under strict ISO 13485 guidelines to ensure high quality standards, electrical safety, and environmentally conscience design as dictated by RoHS (Restriction of Hazardous Substances) directive.

The SVOne family of products conform to safety regulations set forth by IEC 60825-­1 for Laser Emitting Power, signifying safe use on all human patients without any adverse effects to the skin or eye during prolonged use.