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U.S. FDA Medical Device Corneal Topographer Requirements

FDA Medical Device Definition: A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

Registrar Corp assists Corneal Topographer companies with:

  • FDA Corneal Topographer Establishment Registration
  • FDA Corneal Topographer Listing
  • FDA Corneal Topographer Label Requirements and Exceptions
  • FDA Corneal Topographer Import Information
  • FDA Corneal Topographer Detentions (Corneal Topographer Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Corneal Topographer Manufacturers (Corneal Topographer Suppliers)
       - Corneal Topographer Distributors
       - Corneal Topographer Processors
       - Corneal Topographer Repackers
       - Corneal Topographer Relabelers
       - Corneal Topographer Exporters
       - Corneal Topographer Importers
For more information about Corneal Topographer Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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