• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device lens, contact, for reading discomfort
Regulation Description Soft (hydrophilic) contact lens.
Definition This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes.This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNIC
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.5925
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
-
-