• 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 eyelid thermal pulsation system
Regulation Description Eyelid thermal pulsation system.
Definition Therapeutic application of heat and massage to the eyelids.
Physical State Comprised of two components, a single-use disposable unit made of biocompatible polycarbonate and silicone that is inserted around the patient's eyelids, and a handheld control system, which connects to the single-use disposable unit
Technical Method Battery-operated, handheld device that the physician uses in an in-office procedure to control the application of warmth and massage to the eyelids. The handheld device connects to a single-use disposable unit made of biocompatible polycarbonate and silicone that is inserted around the patient's eyelids. The device provides controlled warmth to the inner eyelid surface, close to the location of the meibomian glands, and intermittent massage to the outer eyelid surface to facilitate release of lipid from the cystic meibomian glands.
Target Area eyelids
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeORZ
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type 510(k)
Regulation Number 886.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-