Hironic Co., Ltd.

Korea, Republic · Cheongju-Si Chungbuk

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 7 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

5listed device types

Class I 1Class II 4Class III 0

plus 11 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 1Class 2b 4

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 States11 registration records, 8 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: Hironic Co., Ltd. · HIRONIC CO., LTD.

FDA 510(k) clearances by year

12018

12020

12021

12022

22024

12025

12026

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Laser For Disruption Of Adipocyte Cells For Aesthetic Use 1Powered Laser Surgical Instrument 1Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat 1Massager, Therapeutic, Electric 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260397	SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)	2026-04-06
US	K251334	NEW DOUBLO 2.0	2025-09-29
US	K241099	Plasonic (Plasonic)	2024-11-08
BR	80102519223	Sistema de Terapia por Radiofrequência	Class II
BR	80102519224	Sistema de terapia por ultrassom e RF	Class II
BR	80102519246	Sistema de Terapia por Radiofrequência	Class II
SA	ME0000006223SFDAA00001	Doublo Cartridge	—

Hironic Co., 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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