510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SGQClass II

Intraoral Phototherapy Device

21 CFR 872.5595 / Dental
FDA source (opens on fda.gov)

SGQ is the FDA product code for Intraoral Phototherapy Device, a class II device type, regulated under 21 CFR 872.5595. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SGQ
Device name
Intraoral Phototherapy Device
FDA 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.
Regulation
21 CFR 872.5595
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SGQ

By decision year
1 clearance under product code SGQ with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SGQ by decision year
YearClearances
20251

Applicants with the most clearances

Product code SGQ
Applicants holding the most 510(k) clearances under product code SGQ
ApplicantClearances
Mureva Phototherapy Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code