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Lightlab Imaging, Inc.

USA · Westford

✓ 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

10510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 10 510(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 III 5

6 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class III 1IIa 2

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, 10 510(k), 0 PMA

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: LIGHTLAB IMAGING INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160878	OPTIS Metallic Stent Optimization E.4 SW	2016-06-29
US	K152120	OPTIS Mobile System	2015-10-29
US	K151286	OPTIS Integrated System Mobile Workstation	2015-08-05
CA	85369	C7-XR INTRAVASCULAR IMAGING SYSTEM (OCT)	Class III
CA	87944	ILUMIEN	Class III
CA	92703	ILUMIEN OPTIS SYSTEM	Class III

Lightlab Imaging, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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