Data / Medical devices / South Korea / Hironic Co., Ltd.

Hironic Co., Ltd.: FDA-registered device maker in Yongin-Si Gyeonggi, South Korea, 8 510(k) clearances

Name: Hironic Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hironic Co., Ltd. is registered with the FDA (registration 3014980461) in Yongin-Si Gyeonggi, South Korea. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 31, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014980461
Address: 19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-Si Gyeonggi, South Korea, 16827
Owner or operator: Hironic Co., Ltd. (10058937)
Roles: Manufacturer
First device listed: February 24, 2023
Registered through: 2026
Brand names listed: A-FIT RF Needle Tip (Model: A-FIT RN 1.2), A-FIT RF Needle Tip (Model: A-FIT RN 1.5), A-FIT RF Needle Tip (Model: A-FIT RN 1.8), GP Cable, Ground Pad, InPhiuse, NEW DOUBLO 2, PICOHI and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Laser For Disruption Of Adipocyte Cells For Aesthetic Use	PKT	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Stimulator, Transcutaneous Electrical, Aesthetic Purposes	NFO	2	Manufacturer	accessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	IMI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 31, 2026	K260387	SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)	NFO	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov
April 6, 2026	K260397	SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)	GEI	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov
September 29, 2025	K251334	NEW DOUBLO 2.0	GEI	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov
November 8, 2024	K241099	Plasonic (Plasonic)	GEI	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov
June 24, 2024	K233123	SILKRO	GEI	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov
June 3, 2022	K210084	SILKRO	GEI	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov
October 19, 2021	K201773	PICOHI	GEX	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov
December 1, 2020	K192970	SLIMUS	PKT	Substantially Equivalent	Hironic Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.