510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254024Substantially Equivalent

MR5 Activ Pro

Multi Radiance Medical, Solon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254024 is the FDA 510(k) clearance record for MR5 Activ Pro, a class II device, cleared for Multi Radiance Medical, Inc. on under FDA product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy). FDA's definition for product code NHN reads: "A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and...". FDA records list 3 510(k) clearances for Multi Radiance Medical, Inc., from to . As of , FDA records show no recalls naming K254024.

Clearance record

Decision date
Received
(154 days to decision)
Product code
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Multi Radiance Medical, Inc. 6521 Davis Industrial Pkwy., Solon OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHN

Trailing 12 months
3 clearances under product code NHN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NHN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260