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

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
Product CodeOHT
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
CYDEN LIMITED
  SUBSTANTIALLY EQUIVALENT 3
HOME SKINOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 3
PALOMAR MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 1
Total Device Problems 1

-
-