Data / Medical devices / South Korea / BLUECORE COMPANY Co., Ltd.

BLUECORE COMPANY Co., Ltd.: FDA-registered device maker in Yangsan Gyeongnam, South Korea, 5 510(k) clearances

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

BLUECORE COMPANY Co., Ltd. is registered with the FDA (registration 3014144061) in Yangsan Gyeongnam, South Korea. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 10, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014144061
Address: #, 34, Yari 3-gil, Mulgeum-eup, Yangsan Gyeongnam, South Korea, 50652
Owner or operator: BLUECORE COMPANY Co., Ltd. (10056208)
Roles: Manufacturer
First device listed: November 15, 2017
Registered through: 2026
Brand names listed: IRIS, IRIS Pi Nd YAG Laser, PICORE, Trinity, ZenPro 40

Devices it lists

Device	Product code	Class	Role	Source
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	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
October 10, 2024	K241951	Lasya-Trinity	GEX	Substantially Equivalent	BLUECORE COMPANY Co., Ltd.	accessdata.fda.gov
August 10, 2023	K230268	ZenPro 40	GEX	Substantially Equivalent	BLUECORE COMPANY Co., Ltd.	accessdata.fda.gov
August 9, 2022	K221789	IRIS Pi Q switched Nd YAG laser	GEX	Substantially Equivalent	Bio-Med USA, Inc.	accessdata.fda.gov
October 6, 2021	K212082	Picore	GEX	Substantially Equivalent	Bio-Med USA, Inc.	accessdata.fda.gov
September 8, 2017	K171648	BM.IRIS	GEX	Substantially Equivalent	Bluecore Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 10, 2024. 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.