Data / Medical devices / United States / Biolase MG LLC

Biolase MG LLC: FDA-registered device maker in Corona, CA, United States, 12 510(k) clearances

Name: Biolase MG LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biolase MG LLC is registered with the FDA (registration 3017125161) in Corona, CA, United States. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 21, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3017125161
Address: 4225 Prado Road Suite 102, Corona, CA, United States, 92880
Owner or operator: MEGAGEN IMPLANT CO. LTD (9067358)
Roles: Complaint file establishment, Manufacturer
First device listed: January 2, 2025
Registered through: 2027
Brand names listed: EdgePro, Epic Hygiene, Epic Pro 940, Epic Pro 980, Epic S- Series, Epic X/10/T-Series, Powered Laser Surgical Instrument, WL Express and more

Devices it lists

Device	Product code	Class	Role	Source
Drill, Bone, Powered	DZI	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Laser, Dental, Soft Tissue	NVK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	2	Manufacturer	accessdata.fda.gov
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation	MXF	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
April 21, 2022	K210183	Waterlase iPLus	GEX	Substantially Equivalent	Biolase, Inc.	accessdata.fda.gov
December 22, 2021	K213428	EdgePro	NVK	Substantially Equivalent	Biolase, Inc.	accessdata.fda.gov
December 4, 2019	K192430	Epic 980	GEX	Substantially Equivalent	Biolase, Inc.	accessdata.fda.gov
November 29, 2017	K172771	Epic Pro 940	GEX	Substantially Equivalent	Biolase, Inc.	accessdata.fda.gov
January 11, 2017	K163128	Epic Pro	GEX	Substantially Equivalent	Biolase, Inc.	accessdata.fda.gov
July 28, 2016	K161669	Waterlase Express	GEX	Substantially Equivalent	Biolase, Inc.	accessdata.fda.gov
April 11, 2013	K130465	EPIC 10S	GEX	Substantially Equivalent	Biolase Technology, Inc.	accessdata.fda.gov
September 28, 2012	K121286	EPIC 10	GEX	Substantially Equivalent	Biolase Technology, Inc.	accessdata.fda.gov
August 11, 2010	K101658	WATERLASE MD TURBO PLUS MODEL 7200XXX	GEX	Substantially Equivalent	Biolase Technology, Inc.	accessdata.fda.gov
March 12, 2010	K093852	EZLASE 3 LASER SYSTEM	GEX	Substantially Equivalent	Biolase Technology, Inc.	accessdata.fda.gov
February 11, 2009	K090181	WATERLASE MD	GEX	Substantially Equivalent	Biolase Technology, Inc.	accessdata.fda.gov
July 7, 2004	K031140	WATERLASE	GEX	Substantially Equivalent	Biolase Technology, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 21, 2022. 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.