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Manufacturers and Users of Lasers for Refractive Surgery

The Office Of Device Evaluation (ODE) and Office of Compliance (OC) have issued several documents concerning Manufacturers and Users of Lasers for Refractive Surgery. These documents are available from the CDRH World Wide Web site and from CDRH Facts-On-Demand. Information on obtaining these documents is listed below.

CDRH Facts-On-Demand - To receive the documents concerning Manufacturers and Users of Lasers for Refractive Surgery to your fax machine, call the CDRH Facts-On-Demand (FOD) system at 800.899.0381 or 301.827.0111 from a touch-tone telephone. At the first voice prompt press 1 to access DSMA Facts, at second voice prompt press 2, and then enter the document number from the table below. Then follow the remaining voice prompts to complete your request.

World Wide Web - To obtain any of these documents in Text format, select the word "text" following the title. To obtain any of these documents in PDF format, select the words "PDF Format" following the title.

Shelf_# and Document Title

• 2093 - Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers,
  Text, PDF Format

• 6093 - Update on Excimer Lasers for Nearsightedness, T96-36
  Text

• Letter About Lasers for Refractive Surgery (7/2/97)
  Text, PDF Format

• Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document (9/5/97)
  Text

• FDA Consumer Magazine: Laser Eye Surgery: Is It Worth Looking Into? (7/98)
  Text

(Updated 3/5/2002)

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