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LiteCure, LLC

USA · Fort Worth

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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

3listed device types

Class I 0Class II 3Class III 0

plus 6 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class III 2

4 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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 States6 registration records, 7 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: LiteCure, LLC · LITECURE, LLC · LITECURE LLC

FDA 510(k) clearances by year

12007 · K070400

12010 · K093087

12011 · K103511

22012 · K123031

12013 · K123014

12018 · K173067

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173067	LightForce LTS Model 1000, 1500, 2500, and 4000	2018-02-22
US	K123014	LITECURE THERAPY SYSTEM MODEL LTS-1500	2013-03-29
US	K123031	BWF-5 MEDICAL LASER SERIES	2012-12-03
CA	80486	LITECURE THERAPY LASER SYSTEM	Class III
CA	94498	LIGHTFORCE PRO THERAPY SYSTEM	Class III

LiteCure, LLC

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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