Quality Standards for Laser Devices
Applying a laser device to the scalp is a serious consideration. It is vital to assure that the laser device you are considering to treat your condition is a credible product and with QUALITY OF STANDARDS in place. The bench mark of this level of quality is the attainment of ISO (International Organization for Standardization) certification which is a manufacturing standard around the world, especially for laser devices. In the United States in addition to ISO compliance, companies MUST be compliant with FDA standards for Good Manufacturing Practices (GMP). Meeting the ISO standards and FDA Regulatory requirements, demonstrates a company’s commitment to safety and manufacturing quality of its medical devices.
A company that has achieved ISO certification is expected to have in place a quality management system that describes the methods the company uses to meet its customers’ quality-related expectations. This means that all manufacturing processes are controlled and that each laser must be tested for laser output and validated with the results stored for FDA audits of the manufacturing process to assure compliance.There have been many devices that have been marketed from non-ISO compliant companies that had inconsistent laser output, electrical short circuits, have exceeded laser safety standards, or have simply fallen apart. Many of these companies listed an address as a postal drop, and have disappeared overnight leaving purchasers no recourse for return of their purchase price.In conclusion, when you are considering a laser device to treat your hair, it is recommended that you confirm by asking a company directly : 1) if they have ISO credentials, 2) the address of their company on the web site is an actual office location, 3) what methods they use for validating their laser’s performance and, 4) are they compliant with all FDA standards for GMP.Only when a company confirms that they meet all these requirements can you be assured of the purchase of a quality device. Lexington complies with all ISO guidelines and practices GMP.
Written By: Leonard Stillman, Contributing Author
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