Cleared Traditional

K180197 - Erchonia FX-635 (FDA 510(k) Clearance)

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

K180197 · Erchonia Corporation · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
117d
Days
Class 2
Risk

K180197 is an FDA 510(k) clearance for the Erchonia FX-635. 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 Erchonia Corporation (Melbourne, US). The FDA issued a Cleared decision on May 21, 2018 after a review of 117 days - within the typical 510(k) review window.

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 Erchonia Corporation devices

Submission Details

510(k) Number K180197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date May 21, 2018
Days to Decision 117 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 115d · This submission: 117d
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
NCT02538523 Completed Interventional Industry-sponsored

A Study to Evaluate the Effect of Low Level Laser Light on Low Back Pain

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia FX-635 on Low Back Pain

58
Patients (actual)
3
Sites
Treatment
Purpose
Triple
Masking
Condition studied Low Back Pain
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Trevor Berry, DC
Sponsor Erchonia Corporation (industry)
Started 2016-04-08 → Primary completion 2017-10-07 → Completed 2017-12-10
Primary outcome
Percentage of Participants Whose Change in Pain Rating on the Visual Analog Scale (VAS) Met the Individual Subject Success Criteria
Secondary outcome
Change in Total Score on the Oswestry Disability Index (ODI)
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 52
Devices cleared under the same product code (NHN) and FDA review panel - the closest regulatory comparables to K180197.
Erchonia DPN Laser (Model# EVRL)
K251903 · Erchonia Corporation · Feb 2026
Therapy US
K252273 · Dmc Importa??o E Exporta??o DE Equipamentos Ltda · Dec 2025
Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
K241057 · Wuhan Guangdun Technology Co.,Ltd.. · Jan 2025
Therapy EC, Therapy XT
K232813 · Dmc Importacao E Exportacao DE Equipamentos Ltda · Dec 2024
Erchonia FX-405
K231409 · Erchonia Corporation · Aug 2023
Erchonia GVL
K221987 · Erchonia Corporation · Sep 2022