Cleared Traditional

MR4 Laser (K171354) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence.

K171354 · Multi Radiance Medical · Physical Medicine device
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Jan 2018
Decision
249d
Days
Class 2
Risk

K171354 is an FDA 510(k) clearance for the MR4 Laser. Classified as Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (product code NHN), Class II - Special Controls.

Submitted by Multi Radiance Medical (Solon, US). The FDA issued a Cleared decision on January 13, 2018 after a review of 249 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Multi Radiance Medical devices

Submission Details

510(k) Number K171354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date January 13, 2018
Days to Decision 249 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 115d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NHN Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition 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 Non-thermal Effect, And Is Indicated For Adjunctive Use In Pain Therapy Or Related Indication. It Does Not Provide Therapeutic Topical Heating. The Classification Regulation For Infrared Lamps Describes A Device That Emits Energy In The Infrared Wavelength To Provide Topical Heating And That Is Not Limited To Adjunctive Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Regulatory Insight, Inc.
Kevin Walls

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02940119 Completed Interventional

Neck and Shoulder Pain Research Study

Effects of Phototherapy With Different Sources of Light in Muscle Skeletal Chronic Pain Relief From Neck and Shoulders

72
Patients (actual)
1
Site
Treatment
Purpose
Quadruple
Masking
Condition studied Neck Pain; Shoulder Pain; Chronic Pain; Musculoskeletal Pain
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Ernesto Leal-Junior, PhD
Sponsor University of Nove de Julho
Started 2016-11-01 → Primary completion 2017-03-01 → Completed 2017-04-01
Primary outcome
Pain assessment
Secondary outcome
Rage of Motion (ROM)
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - NHN Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

All 17
Devices cleared under the same product code (NHN) and FDA review panel - the closest regulatory comparables to K171354.
Erchonia FX-635
K190572 · Erchonia Corporation · Jun 2019
Erchonia FX-635
K180197 · Erchonia Corporation · May 2018
Collagentex Rx-6
K180585 · Tanses Technologies, Inc. · May 2018
Erchonia EVRL
K152196 · Erchonia Corporation · Feb 2016
Erchonia PL Touch
K153052 · Erchonia Corporation · Jan 2016