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Alma Lasers , Ltd.

Israel · Nuernberg

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

18listed device types

Class I 2Class II 16Class III 0

plus 56 registration records and 34 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class III 3

25 including historic records

TWTaiwanTFDA

12valid device licences

Class I 1Class II 11

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Business type not stated 1Import 2

AUAustraliaTGA ARTG

10active ARTG entries

IIb 10

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

8active registrations

Class 2b 8

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 States56 registration records, 34 510(k), 0 PMA, 2 excluded

Brazil2 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: ALMA LASERS LTD. · ALMA LASERS, INC. · ALMA LASERS GMBH · ALMA LASERS LTD

FDA 510(k) clearances by year

22007

42008

32009

12010

32011

22012

22014

12016

32017

22018

22021

22022

22023

12024

32025

12026

FDA listed device types

showing 8 of 18

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Lamp, Infrared, Therapeutic Heating 1Light, Ultraviolet, Dermatological 1Electrosurgical, Cutting & Coagulation & Accessories 1Laser For Gastro-Urology Use 1Light Based Over The Counter Wrinkle Reduction 1System, Suction, Lipoplasty 1Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251684	Alma TED+ System	2026-06-05
US	K250071	Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories	2025-09-24
US	K251230	The Alma Hybrid Laser System	2025-05-21
BR	80380269018	SISTEMA DE TRATAMENTO DE PELE ACCENT PRIME	Class II
BR	80380269020	SISTEMA DE TRATAMENTO DE PELE OPUS	Class II
CA	82511	LEDA SYSTEM	Class III
CA	90074	EXELO 2 SYSTEM	Class III
CA	68935	SONATA HAIR REMOVAL DIODE LASER SYSTEM	Class III

Alma Lasers , Ltd.

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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