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U.S. FDA Medical Device Laser Generating Gas Requirements

FDA Medical Device Definition: (1)A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2)An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Registrar Corp assists Laser Generating Gas companies with:

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