FDA.reportPublic FDA data

510(k) K254024

Device
MR5 Activ Pro
Applicant
Multi Radiance Medical, Inc.
510(k) number
K254024
Product code
NHN
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-19
Date received
2025-12-16
Regulation
890.5500
Classification name
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Glenn Persello
Address
6521 Davis Industrial Pkwy. Solon OH US 44139 44139

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NHN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251903Erchonia DPN Laser (Model# EVRL)Erchonia Corporation2026-02-19
K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda2025-12-12
K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..2025-01-24
K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda2024-12-19
K231409Erchonia FX-405Erchonia Corporation2023-08-11
K212189FibroLuxMulti Radiance Medical2022-09-02
K221987Erchonia GVLErchonia Corporation2022-09-01
K203337PainTB, PainTJPtech Co., Ltd.2022-02-11
K212595Erchonia FX-405Erchonia Corporation2021-11-12
K211186Erchonia XLR8Erchonia Corporation2021-10-22
K191257Erchonia EVRLErchonia Corporation2019-08-08
K190572Erchonia FX-635Erchonia Corporation2019-06-01
K180197Erchonia FX-635Erchonia Corporation2018-05-21
K180585Collagentex Rx-6Tanses Technologies, Inc.2018-05-11
K171354MR4 LaserMulti Radiance Medical2018-01-13