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

Bison Medical Co., Ltd: FDA-registered device maker in Geumcheon gu Seoul, South Korea, 6 510(k) clearances

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

Bison Medical Co., Ltd is registered with the FDA (registration 3011555967) in Geumcheon gu Seoul, South Korea. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 2, 2018. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Bison Medical Co., Ltd

FDA registration number: 3011555967
Address: Ace High-end Tower 6 # 234 Beotkkot-Ro, Gasan dong, Geumcheon gu Seoul, South Korea, 153-802
Owner or operator: Bison Medical Co., Ltd (10048310)
Roles: Contract manufacturer, Manufacturer
First device listed: April 8, 2015
Registered through: 2026
Brand names listed: ACCENTO / HWA Dual/Single laser, CELLENE, CYMA, Dental 5 Multi, Denti 5, Lucid Q-PTP, Ruby Star

Devices it lists

Device	Product code	Class	Role	Source
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer, 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
November 2, 2018	K182270	Cellene CO2 Laser System	GEX	Substantially Equivalent	Bio-Med USA, Inc.	accessdata.fda.gov
May 15, 2017	K163638	Dental 5 Multi Diode laser	GEX	Substantially Equivalent	Bio-Med USA, Inc.	accessdata.fda.gov
November 2, 2016	K161670	Lucid Q-PTP / HWA 55	GEX	Substantially Equivalent	Bison Medical Co, Ltd.	accessdata.fda.gov
April 22, 2016	K160227	ACCENTO / HWA Dual/Single laser	GEX	Substantially Equivalent	Bison Medical Co, Ltd.	accessdata.fda.gov
December 22, 2015	K150997	RUBY STAR	GEX	Substantially Equivalent	Bison Medical Co, Ltd.	accessdata.fda.gov
April 3, 2015	K150027	CYMA	GEX	Substantially Equivalent	Whitecap Technologies, LLC	accessdata.fda.gov

Compare with other makers

Updated November 2, 2018. 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.