Cleared Traditional

K132940 - ERCHONIA ALLAY

K132940 is an FDA 510(k) clearance for ERCHONIA ALLAY, manufactured by Erchonia Medical, Inc.. The device is a Class 2 Physical Medicine device with product code NHN cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K132940 · Erchonia Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
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Apr 2014
Decision
207d
Days
Class 2
Risk

K132940 is an FDA 510(k) clearance for the ERCHONIA ALLAY. 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 Medical, Inc. (Littleton, US). The FDA issued a Cleared decision on April 14, 2014 after a review of 207 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.

FDA 510(k) Submission Details - K132940

510(k) Number K132940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2013
Decision Date April 14, 2014
Days to Decision 207 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
91d slower than avg
Panel avg: 116d · This submission: 207d
Pathway characteristics
Predicate-based equivalence.

NHN Device Classification - Class 2, Special Controls

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.

Clinical Evidence

ClinicalTrials.gov
NCT01835743 Completed Interventional Industry-sponsored

Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia HP Scanner (HPS) Laser on Chronic Heel Pain

69
Patients (actual)
2
Sites
Treatment
Purpose
Triple
Masking
Condition studied Plantar Fasciitis
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Michael Coughlin, M.D.
Sponsor Erchonia Corporation (industry)
Started 2012-02-01 → Primary completion 2012-05-01 → Completed 2013-05-01
Primary outcome
Number of Participants Who Attained a Change of -30% or Greater in the VAS Score
Secondary outcome
Change in Heel Pain Score on the Visual Analog Scale (VAS)
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 53
Devices cleared under the same product code (NHN) and FDA review panel - the closest regulatory comparables to K132940.
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MLS-AC DERMA SCANNER
K101430 · Erchonia Corporation · Jun 2010