When did Lasik Receive FDA Approval?
The Food and Drug Administration (FDA) first approved the excimer laser for patients with mild to moderate nearsightedness in October 1995. The FDA approved the excimer laser to correct astigmatism in April 1997. With some lasers, Lasik is not officially approved by the FDA – but not to worry. The FDA approves medical devices, not medical procedures. The combination of Automated Lamellar Keratoplasty (ALK) and the excimer laser to create Lasik does not require specific FDA approval. This is considered an “off label” use of the excimer laser and is totally appropriate.
