Data / Medical devices / United States / Erchonia Corporation

Erchonia Corporation: FDA-registered device maker in Fountain Inn, SC, United States, 20 510(k) clearances

Name: Erchonia Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Erchonia Corporation is registered with the FDA (registration 2032513) in Fountain Inn, SC, United States. It lists 7 device types. The FDA files 20 510(k) clearances under its listings, the newest dated December 15, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2032513
FEI number: 3003462036
Address: 112 Southchase Blvd, Fountain Inn, SC, United States, 29644
Owner or operator: ERCHONIA CORPORATION (9047254)
Roles: Complaint file establishment, Manufacturer, Remanufacturer
First device listed: February 28, 2002
Registered through: 2026
Brand names listed: EML, EML-RM, EVRL, EVRL-RM, Emerald-Reman; Emerald-RM; SHL-RM, Emerald; SHL, Erchonia CLX, Erchonia CLX-Reman, Erchonia EVRL-OTC and more

Devices it lists

Device	Product code	Class	Role	Source
Fat Reducing Low Level Laser	OLI	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	PDZ	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Massager, Therapeutic, Manual	LYG	1	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy	NHN	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 15, 2025	K252574	Erchonia CLX (Model # CFL)	OLI	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
September 12, 2025	K251843	Erchonia EVRL	OLP	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
January 10, 2025	K243811	Erchonia Zerona® VZ8	OLI	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
September 1, 2022	K221987	Erchonia GVL	NHN	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
November 12, 2021	K212595	Erchonia FX-405	NHN	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
October 22, 2021	K211186	Erchonia XLR8	NHN	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
January 13, 2020	K192544	Erchonia Emerald	OLI	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
August 8, 2019	K191257	Erchonia EVRL	NHN	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
June 1, 2019	K190572	Erchonia FX-635	NHN	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
December 16, 2016	K162578	Zerona Z6 OTC	OLI	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
June 3, 2016	K153164	LunulaLaser	PDZ	Substantially Equivalent	Erchonia Medical, Inc.	accessdata.fda.gov
January 4, 2016	K153052	Erchonia PL Touch	NHN	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
September 16, 2013	K130996	ERCHONIA EMERGE	NHN	Substantially Equivalent	Erchonia Medical, Inc.	accessdata.fda.gov
May 17, 2013	K130922	ERCHONIA VERJU LASER SYSTEM WITH MASSAGER	OLI	Substantially Equivalent	Erchonia Medical, Inc.	accessdata.fda.gov
April 23, 2013	K130741	ERCHONIA PL5000	NHN	Substantially Equivalent	Erchonia Medical, Inc.	accessdata.fda.gov
January 25, 2013	K123237	ZERONA 2.0 LASER	OLI	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
August 23, 2012	K121695	ERCHONIA ZERONA	OLI	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
August 23, 2012	K121690	ETCHONIA ZERONA ARMS	OLI	Substantially Equivalent	Erchonia Corporation	accessdata.fda.gov
April 24, 2008	K072206	ERCHONIA EML LASER	NHN	Substantially Equivalent	Erchonia Medical, Inc.	accessdata.fda.gov
January 17, 2002	K012580	ERCHONIA PL2000	NHN	Substantially Equivalent	Tuco Innovations, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.