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U.S. FDA Medical Device Surgical Headlight Requirements

FDA Medical Device Definition: A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.

Registrar Corp assists Surgical Headlight companies with:

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