Is LASIK FDA approved?

Yes, LASIK surgery is FDA-approved and has been since 1999.

FDA Approval History

• 1995: FDA approved the excimer laser for PRK (photorefractive keratectomy)
• 1999: FDA approved LASIK for treating myopia, hyperopia, and astigmatism
• 2000s: Various wavefront-guided and bladeless LASIK technologies received approval
• 2016: FDA approved SMILE (Small Incision Lenticule Extraction) as an alternative

What FDA Approval Means

FDA approval indicates that:

• Clinical trials demonstrated safety and effectiveness
• Benefits outweigh risks for appropriate patients
• Manufacturing quality meets strict standards
• Post-market surveillance monitors ongoing safety

FDA Prescription Limits

The FDA has approved LASIK for specific prescription ranges:

• Myopia: Up to -12.00 diopters
• Hyperopia: Up to +6.00 diopters
• Astigmatism: Up to 6.00 diopters

The FDA's Position Today

The FDA continues to monitor LASIK safety. Their official position states that LASIK is safe and effective when:

• Patients are properly screened
• The procedure is performed by a qualified surgeon
• Appropriate technology is used
• Patients understand potential risks

The FDA's PROWL study (2014) reinforced LASIK's safety profile with 96-99% patient satisfaction rates.