FDA Approved and Cleared Medical Lasers

The two basic types of FDA approved items are one of two categories: Approved or Cleared. The FDA will assign a “510K” number when the device is ready for market and has been thoroughly tested. A Medical Director is required on board in all US states.

1) Approved Medical Devices-FDA approval is necessary to make sure patients using certain medical devices will be safe while utilizing the product. Devices go through rigorous study and examination before being allowed to be approved into the health care market. It also needs to be proven that the medical device will not only not do harm, but also that it will do good. The entire purpose of a medical device is to improve someone’s health, and if the item does not pass that inspection, it will not receive Approval or Clearance by the FDA.

2) Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. FDA Clearance is as equal for usage in the medical field as FDA Approved. These devices are able to be marketed in used in the USA with proper training and certification.