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Statement on Refractive Lasers

Issue: January 1996

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US Food and Drug Administration
Center for Devices and Radiological Health
Division of Ophthalmic Devices

Statement on Refractive Lasers

The following document was released at a 22 January 1996 meeting of the CDRH Ophthalmic Devices Advisory Panel.

PRIMARY CARE OPTOMETRY NEWS provides this document as a service to readers. Questions should be directed to the CDRH.

Statement on Refractive Lasers

LASIK has not been evaluated for safety and effectiveness by the Agency and we have not approved any laser for LASIK. Therefore:

• Companies may not market or promote lasers for LASIK.
• Physicians may not market or promote lasers for LASIK.
• We encourage companies and physicians to submit applications for IDEs to study LASIK.
• Physicians' use of a laser approved only for PRK is a practice of medicine issue as long as the physician does not market or promote the laser for LASIK.

Concern has been expressed that the individual performing PRK has competence to perform the PRK procedure.

• The Agency requires that manufacturers of approved refractive lasers bear the primary responsibility for training individuals who use their laser. The Agency requires that a training program accompany the approved laser. The content of the training program is the responsibility of the manufacturer.
• The Agency has no position with regards to whether the individual is an optometrist, ophthalmologist, or other kind of practitioner. This is a matter for the States to decide.

Advertising and promotion of an approved refractive laser must provide balance by providing adequate information about the risks of the device if the benefits are discussed.