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Syneron Medical, Ltd.

Israel · Yokneam Illit

✓ Record-verifiedregistrations found in 6 markets

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

35510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 35 510(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

14active device licences

Class II 6Class III 8

16 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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, 35 510(k), 0 PMA, 7 excluded

Canada14 confirmed, 0 excluded

Manufacturer names merged into this page: SYNERON MEDICAL LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170370	ULTRASHAPE POWER SYSTEM	2017-05-15
US	K163415	SlimShape System	2017-04-20
US	K162163	UltraShape System	2016-11-17
CA	67600	COSMETIC LASERS	Class III
CA	36359	AURORA HANDPIECES	Class II
CA	61347	AURORA SR	Class III

Syneron Medical, Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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