SGQ · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5595
Classification
FDA Product Code
SGQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.5595
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.