Cleared Traditional

Erchonia EVRL

K191257 · Erchonia Corporation · General & Plastic Surgery

Aug 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K191257 is an FDA 510(k) clearance for the Erchonia EVRL, a Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (Class II — Special Controls, product code NHN), submitted by Erchonia Corporation (Melbourne, US). The FDA issued a Cleared decision on August 8, 2019, 90 days after receiving the submission on May 10, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K191257 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2019
Decision Date	August 08, 2019
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

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 II — 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.