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U.S. FDA Medical Device Infrared Lamp Requirements: Infrared Lamp

FDA Medical Device Definition: An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating

Registrar Corp assists Infrared Lamp companies with:

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

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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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