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Lexington International, LLC

USA · Alexandria

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Singapore, Australia, Israel — 5 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

8510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States0 registration records, 8 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: LEXINGTON INTERNATIONAL LLC

Market	Identifier	Name	Class / date
US	K180885	HairMax Laser	2018-06-20
US	K142573	HairMax LaserComb, HairMax LaserComb	2014-12-01
US	K112524	HAIRMAX LASERCOMB	2011-09-26
BR	80117589110	HairMax	Class II

Lexington International, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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