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Labeling Requirements for Keratomes Used in LASIK Surgery

This guidance clarifies FDA's position on labeling keratomes for LASIK indication, providing requirements for manufacturers to either immediately label their devices for LASIK or submit a new 510(k) based on specific criteria.

  1. Review existing 510(k) documentation to determine if it contains all required specifications and testing information
  2. If documentation is complete:
    • Update device labeling to include LASIK indication
    • Consider submitting new 510(k) to update recorded indication statement
  3. If documentation is incomplete:
    • Prepare new 510(k) submission including all required elements
    • Conduct necessary testing to validate flap specifications
    • Document methods and components for flap creation
    • Develop comprehensive instructions for flap creation
  4. Ensure compliance with least burdensome approach principles when preparing submissions
  5. Maintain records of all specification validations and testing results

Key Considerations

Non-clinical testing

  • Validation testing protocols and results for flap specifications
  • Testing to demonstrate accuracy and variability of the corneal flap produced

Labelling

  • Must include specifications for:
    • Type of hinge or flap (nasal or superior)
    • Thickness(s) of cut
    • Flap diameter(s)
    • Hinge width(s)
  • Must include instructions for creating a flap

Safety

  • Description of methods and components for variable hinge, diameter, or thickness production
  • Description of blade halting mechanism for hinge or flap creation

Other considerations

  • 21 CFR 807.87: Requirements for 510(k) submission

Original guidance

  • Labeling Requirements for Keratomes Used in LASIK Surgery
  • HTML / PDF
  • Issue date: 2001-06-20
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket
  • ReguVirta summary file ID: be9be31dc26d5d5890c47cdd60f945b7
This post is licensed under CC BY 4.0 by the author.