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CUTERA, INC.

USA · Brisbane

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, 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

6listed device types

Class I 0Class II 6Class III 0

plus 15 registration records and 31 510(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

3active device licences

Class III 3

10 including historic records

TWTaiwanTFDA

15valid device licences

Class I 1Class II 14

SGSingaporeHSA SMDR

5device registrations

CLASS C 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

8active ARTG entries

IIa 1IIb 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 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 States15 registration records, 31 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: CUTERA, INC.

FDA 510(k) clearances by year

12004

32005

22007

22008

12009

22011

12012

22013

32014

32016

32017

22018

32022

22023

12025

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Lamp, Infrared, Therapeutic Heating 1Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Massager, Vacuum, Radio Frequency Induced Heat 1Powered Laser Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251149	AviClear Laser System	2025-07-11
US	K233237	xeo+ Family	2023-12-15
US	K230660	AviClear Laser System	2023-06-06
CA	26642	LYRA I LASER SYSTEM	Class III
CA	66708	GEMINI LASER SYSTEM	Class III
CA	68871	IRIDEX VARILITE LASER SYSTEM	Class III

CUTERA, 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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