LASIK FAQs

FDA does not provide comparisons between refractive lasers. FDA approves the safety and effectiveness of a device independent of any other product. However, you are encouraged to review the approval documents to assess the capabilities of specific laser systems and make your own comparisons. The approval number for each laser on the FDA-Approved Lasers page is linked to these documents, which provide additional, detailed information about the clinical trial results and indications for use. Discuss any concerns you may have with your doctor.

The difference between traditional LASIK and “All-Laser LASIK” (also known as “Bladeless LASIK”) is the method by which the LASIK flap is created. In “All-Laser LASIK”, a laser device called a laser keratome, is used to cut a corneal flap for LASIK surgery. This is a newer method to create a corneal flap than the traditional method of using a microkeratome, a mechanical device with a blade. There is no absolute agreement among eye surgeons on the better choice for flap creation. Some of the factors a surgeon considers when choosing a preferred method of flap creation during LASIK are as follows:

- Quality of vision
- Rate of complications
- Pain during and after surgery
- Precision of flap size and thickness
- Time to recovery of vision
- Expense

Discuss with your doctor any questions and concerns you have about how they chose their preferred method of flap creation.

Data in the Approval Orders and related documents summarizes the outcomes from the clinical trials submitted to the FDA for each approved device. Links to these documents are included on the FDA-Approved Lasers page.