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ERCHONIA CORPORATION

USA · Fountain Inn

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 2Class II 5Class III 0

plus 21 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 5

22 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IIa 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States21 registration records, 26 510(k), 0 PMA, 2 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: ERCHONIA CORPORATION

FDA 510(k) clearances by year

22010

22012

12013

22014

22015

32016

12018

22019

12020

22021

22022

22023

32025

12026

FDA listed device types

Fat Reducing Low Level Laser 1Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 1Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy 1Over-The-Counter Powered Light Based Laser For Acne 1Powered Laser Surgical Instrument 1Massager, Therapeutic, Electric 1Massager, Therapeutic, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251903	Erchonia DPN Laser (Model# EVRL)	2026-02-19
US	K252574	Erchonia CLX (Model # CFL)	2025-12-15
US	K251843	Erchonia EVRL	2025-09-12
CA	90115	ZERONA-AD	Class II
CA	91276	PL5	Class II
CA	91344	EML	Class II

ERCHONIA CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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