LASIK Eye Center of Silicon Valley - Dr. Gary Kawesch

The US Food and Drug Administration (FDA) regulates the sale of medical devices and monitors the ongoing safety of these devices, including the lasers used in LASIK. The FDA does not regulate the procedures in which the devices are used.

Even if a laser is not approved by the FDA, a doctor may legally use the device; however, as a patient, you should note that lasers not approved by the FDA have not been evaluated by a governmental regulatory agency.

You can find a long list of FDA-approved lasers for LASIK on the FDA website. Included in the list are the following lasers:
•B&L Zyoptix
•LADARVision 4000 Excimer Laser System
•Mel 80 Excimer Laser System

To monitor the ongoing safety of medical devices that have been approved, the FDA gathers reports from the following sources:

•MedWatch. This FDA reporting program lets consumers, healthcare professionals, and manufacturers report serious complications related to medical devices and drugs.

•SightNet. In this program, healthcare professionals can report concerns specifically regarding ophthalmic medical devices.

The FDA cannot create any kind of rating system ranking the devices. For example, the FDA cannot say one device is better or safer than another.

If you live in San Francisco and would like to learn more about LASIK surgery, please contact the experienced LASIK eye surgeons at the Laser Eye Center of Silicon Valley to schedule a consultation.