Cleared Traditional

Erchonia FX-635

K190572 · Erchonia Corporation · Physical Medicine

Jun 2019

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K190572 is an FDA 510(k) clearance for the Erchonia FX-635, 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 June 1, 2019, 87 days after receiving the submission on March 6, 2019. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K190572 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2019
Decision Date	June 01, 2019
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
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.