FDA Approval Status for Laser Tattoo Removal

In the past, laser tattoo removal was a painful process that involved the use of chemicals and tissue abrasion, which often left patients scarred. However, today’s patients can expect good results and little discomfort with lasers approved by the U.S. Food and Drug Administration (FDA).

FDA Approval Process

Persons wishing to undergo tattoo removal should choose a specialist who only uses lasers approved for tattoo removal. In order to receive approval from the FDA, the laser manufacturer must demonstrate that the device is safe and effective for a particular use. Therefore, valid research must be conducted prior to application.

After completing the application process, the manufacturer releases its research findings and methods to the FDA, where it is reviewed by a special panel. The panel will access the safety, efficacy and risks associated with the laser procedure before they issue approval.

The Q-Switched Ruby Laser (QSRL) and the Q-Switched Nd:YAG laser have been approved by the FDA. The Q-Switched is actually a family of lasers comprised of several different models. They are highly effective in removing black and blue-black inks. Several different Q-Switched lasers under various brand names have been approved. Laser tattoo removal may take several sessions before the ink is unnoticeable.

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