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U.S. FDA Medical Device Ophthalmic Knife Requirements


FDA Medical Device Definition: A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Registrar Corp assists Ophthalmic Knife companies with:

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