• 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 light based over-the-counter hair removal
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Physical State Use of thermal energy
Technical Method Use of thermal energy to kill hair follicles for hair removal
Target Area All body areas except the face
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOHT
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4810
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
-
-