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U.S. FDA Medical Device Gynecologic Surgical Laser Requirements: Gynecologic Surgical Laser

FDA Medical Device Definition: A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix

Registrar Corp assists Gynecologic Surgical Laser companies with:

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