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Cynosure, Inc.

USA · Westford

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

23listed device types

Class I 9Class II 14Class III 0

plus 104 registration records and 107 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

24active device licences

Class II 3Class III 21

58 including historic records

TWTaiwanTFDA

pendingnot queried

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 States104 registration records, 107 510(k), 0 PMA, 3 excluded

Brazil1 confirmed, 1 excluded

Canada24 confirmed, 2 excluded

Manufacturer names merged into this page: CYNOSURE, LLC · CYNOSURE INC. · CYNOSURE, INC. · CYNOSURE, LLC.

FDA 510(k) clearances by year

42006

42007

42008

62009

12010

12011

42012

22013

62014

42015

22016

32017

22018

22019

22020

12021

22022

12023

12024

12026

FDA listed device types

showing 8 of 23

Electrosurgical, Cutting & Coagulation & Accessories 1Electrosurgical Patient Return Electrode 1Lamp, Infrared, Therapeutic Heating 1Set, Anesthesia, Paracervical 1System, Suction, Lipoplasty 1Apparatus, Exhaust, Surgical 1Massager, Vacuum, Light Induced Heating 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261570	PICOSURE WORKSTATION	2026-06-17
US	K240396	Elite iQ PRO (M122K1)	2024-03-08
US	K230510	MyEllevate	2023-07-06
BR	80341940007	SISTEMA EMERGE DE LASER FRACIONADO	Class II
CA	11541	HIGH FREQUENCY ELECTRO-SURGICAL GENERATOR	Class III
CA	36232	LONG PULSE INFRARED LASER FAMILY	Class III
CA	60247	PALOMAR ESTELUX SYSTEM	Class III

Cynosure, 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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