SGQ · Class II · 21 CFR 872.5595

FDA Product Code SGQ: Intraoral Phototherapy Device

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.

Leading manufacturers include Mureva Phototherapy, Inc..

1
Total
0
Cleared
338d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Intraoral Phototherapy Device Devices (Product Code SGQ)

1 devices
1–1 of 1

About Product Code SGQ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SGQ since 2025, with 0 receiving FDA clearance (average review time: 338 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SGQ devices are reviewed by the Dental panel. Browse all Dental devices →