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DBM Corporation USA: FDA-registered device maker in Mission Viejo, CA, United States, 4 510(k) clearances

Name: DBM Corporation USA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DBM Corporation USA is registered with the FDA (registration 3013376016) in Mission Viejo, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3013376016
Address: 23263 Madero Ste B, Mission Viejo, CA, United States, 92691
Owner or operator: DBM Corp USA (10053931)
Roles: Repackager or relabeler
First device listed: January 23, 2017
Registered through: 2027
Brand names listed: LyncMed, MIRACU, Mirapen, SYLFIRM X, SmartLux

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Pad, Eye	HMP	1	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Powered Microneedle Device	QAI	2	Repackager or relabeler	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Repackager or relabeler	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 11, 2023	K230420	Dr. pen Microneedling System	QAI	Substantially Equivalent	Guangzhou Ekai Electronic Technology Co., Ltd.	accessdata.fda.gov
April 22, 2020	K200185	SYLFIRM X	GEI	Substantially Equivalent	VIOL Co., Ltd.	accessdata.fda.gov
November 14, 2018	K172602	Miracu	NEW	Substantially Equivalent	Feeltech Co., Ltd.	accessdata.fda.gov
October 1, 2012	K120460	SMARTLUX	GEX	Substantially Equivalent	Medmix Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 11, 2023. 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.