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U.S. FDA Medical Device Needle-Type Epilator Requirements

FDA Medical Device Definition: A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only.

Registrar Corp assists Needle-Type Epilator companies with:

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