FDA.reportPublic FDA data

ERCHONIA CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20325133003462036ERCHONIA CORPORATION1N2026-01-01112 Southchase Blvd Fountain Inn SC US 29644

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00858985006001Base Station - MEDICAL - Desk Top Model Docking Station - includes 2 XLR8 & 1 EVRL low level laser devices(888) 242-0571info@erchonia.com
00858985006025EVL - VETERINARY - Handheld Low Level Laser - 2 diodes 640nm & 405 nm 7.5 mW - includes induction charger(888) 242-0571info@erchonia.com
00858985006087VLS - VETERINARY - Handheld Low Level Laser - 2 diodes 640nm 10mW - includes induction charger(888) 242-0571info@erchonia.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
201381374868508K252574Erchonia CLX (Model # CFL)OLI2025-12-15
201381213256538K251843Erchonia EVRLOLP2025-09-12
201381972370370K243811Erchonia Zerona® VZ8OLI2025-01-10
201381557902101K221987Erchonia GVLNHN2022-09-01
201382041125826K212595Erchonia FX-405NHN2021-11-12
201381381126771K211186Erchonia XLR8NHN2021-10-22
201381004004198K192544Erchonia EmeraldOLI2020-01-13
201381966534948K191257Erchonia EVRLNHN2019-08-08
201381303486690K190572Erchonia FX-635NHN2019-06-01
201381904612055K162578Zerona Z6 OTCOLI2016-12-16
201381322487063K153164LunulaLaserPDZ2016-06-03
201381250456849K153052Erchonia PL TouchNHN2016-01-04
201381372841456K130996ERCHONIA EMERGENHN2013-09-16
201381075273973K130922ERCHONIA VERJU LASER SYSTEM WITH MASSAGEROLI2013-05-17
201381614073180K130741ERCHONIA PL5000NHN2013-04-23
201381687749990K123237ZERONA 2.0 LASEROLI2013-01-25
201381115168366K121695ERCHONIA ZERONAOLI2012-08-23
201381889686896K121690ETCHONIA ZERONA ARMSOLI2012-08-23
201381603399383K072206ERCHONIA EML LASERNHN2008-04-24
201381553054977K062792ERCHONIA IOTO_240EGJ2007-03-01
201381462220404K012580ERCHONIA PL2000NHN2002-01-17
201381889058613

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHN102022-09-01
OLI82025-12-15
OLP12025-09-12
PDZ12016-06-03
EGJ12007-03-01

PMN#

ZERONA

2014-05-12

ERCHONIA CORPORATION

GUDID#