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U.S. FDA Medical Device Photokeratoscope 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 Photokeratoscope companies with:

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