How does the FDA classify or certify laser machines?

The FDA classifies or certifies laser machines primarily by the hazards they pose, which is essential for ensuring safety during their use. This classification system helps to categorize devices based on their potential risks and the level of control required to manage those risks. For instance, lasers are typically classified into categories ranging from Class I to Class IV, with Class I being the least hazardous and Class IV posing significant risks due to their potential to cause severe injuries.

This classification process is crucial as it informs manufacturers and practitioners about the necessary safety measures, required training for operators, and regulatory compliance needed to safely use the devices. By focusing on the hazards, the FDA helps to protect both patients and practitioners from potential injuries that can arise from improper use of laser technology. Other factors, such as patient reviews, manufacturer reputation, and treatment effectiveness, play a role in the medical device industry but are not the primary basis for FDA classification or certification.