510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN240077Unknown

MuReva OM™

Mureva Phototherapy Inc., Strongsville OH / Direct, Unknown
FDA source (opens on fda.gov)

DEN240077 is the FDA 510(k) clearance record for MuReva OM™, a class II device, cleared for Mureva Phototherapy, Inc. on under FDA product code SGQ (Intraoral Phototherapy Device). FDA's definition for product code SGQ 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". FDA records list one 510(k) clearance for Mureva Phototherapy, Inc. As of , FDA records show no recalls naming DEN240077.

Clearance record

Decision date
Received
(338 days to decision)
Product code
SGQ Intraoral Phototherapy Device
Regulation
21 CFR 872.5595
Device class
Class II
Review panel
Dental
Applicant
Mureva Phototherapy, Inc. 8300 Dow Cir., Strongsville OH
Third party review
No

Clearances, product code SGQ

Trailing 12 months
1 clearance under product code SGQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGQ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260