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InMode , Ltd.

Israel · Yokneam

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

10listed device types

Class I 1Class II 9Class III 0

plus 37 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 4Class III 2

15 including historic records

TWTaiwanTFDA

11valid device licences

Class II 11

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

IIa 3IIb 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 3

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 States37 registration records, 15 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: INMODE LTD.

FDA 510(k) clearances by year

12019

32020

22021

12022

22023

42024

12025

12026

FDA listed device types

showing 8 of 10

Electrosurgical, Cutting & Coagulation & Accessories 1Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Stimulator, Muscle, Powered 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1Massager, Vacuum, Light Induced Heating 1Vibrator For Therapeutic Use, Genital 1Massager, Vacuum, Radio Frequency Induced Heat 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251254	Ignite RF System	2026-01-15
US	K251632	Optimas MAX System	2025-06-26
US	K242598	DEFINE System (AG612444A)	2024-11-14
BR	10343659010	SISTEMA EVOKE	Class II
BR	10343659009	Sistema Evolve	Class II
CA	80162	BODYTITE	Class III
CA	84237	BODYTITE HANDPIECES	Class II
CA	86097	FRACTORA HANDPIECE WITH TIPS	Class II

InMode , 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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