SGQ — Intraoral Phototherapy Device Class II

FDA Device Classification

Classification Details

Product Code
SGQ
Device Class
Class II
Regulation Number
872.5595
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN240077mureva phototherapyMuReva OM™November 26, 2025