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Medical Laser, Inc.

USA · Minneapolis

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

2listed device types

Class I 0Class II 2Class III 0

plus 4 registration records and 64 510(k), 3 PMA

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

2active device licences

Class II 2

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States4 registration records, 64 510(k), 3 PMA, 112 excluded

Brazil0 confirmed, 14 excluded

Canada2 confirmed, 16 excluded

Manufacturer names merged into this page: MEDICAL LASER TECHNOLOGIES LTD. · Summus Medical Laser, LLC · FOTONMEDIX MEDICAL LASER CO., LTD. · GML GERMAN MEDICAL LASER GMBH · SUMMUS MEDICAL LASER, LLC

FDA 510(k) clearances by year

41995

11996

61997

21998

21999

22000

12003

12004

12005

12007

22008

12009

12011

12012

12013

32017

22018

22022

12024

12025

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241601	EMS (FlexPulse, MagnaCore, Magnetika)	2025-02-25
US	K232133	Co2 Laser System, Models: PureLase And VanLase	2024-04-16
US	K222673	Alexandrite and Nd:YAG Laser models CANLASE and TORLASE	2022-11-17
CA	89918	BIOLAS SOFTLASER	Class II
CA	90287	TINNIMED 2	Class II

Medical Laser, Inc.

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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