Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 intraoral phototherapy device
Definition An intraoral phototherapy device is an intraoral, non-ionizing, light-based device that is intended for non-surgical treatment of oral conditions such as oral mucositis.
Physical State A low-level light device with a control unit and user interface designed to deliver non-ionizing light energy at a controlled light dose.
Technical Method The light control unit emits dose-controlled low level non-ionizing light energy to the oral mucosa tissue.
Target Area Oral Mucosa
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeSGQ
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5595
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-