Medical Device Manufacturer · US , Clemente , CA

Biolase Technology, Inc.

31 submissions · 31 cleared · Since 1995
31
Total
31
Cleared
0
Denied

Biolase Technology, Inc. — FDA 510(k) Submissions

Biolase Technology, Inc. has submitted 31 FDA 510(k) premarket notifications since 1995, of which 31 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation, Toothbrush, Manual, Lamp, Infrared, Therapeutic Heating, Handpiece, Air-powered, Dental . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
WATERLASE IPLUS ALL TISSUE LASER
K122368 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 2013 269d
EPIC 10S
K130465 · GEX Powered Laser Surgical... · General & Plastic Surgery
Apr 2013 45d
DIOLASE 10S
K121327 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2013 275d
EPIC 10
K121286 · GEX Powered Laser Surgical... · General & Plastic Surgery
Sep 2012 151d
WATERLASE MD TURBO PLUS MODEL 7200XXX
K101658 · GEX Powered Laser Surgical... · General & Plastic Surgery
Aug 2010 61d
EZLASE 3 LASER SYSTEM
K093852 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 2010 86d
WATERLASE MD, MODEL 7100102
K091746 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 2009 174d
WATERLASE MD
K083927 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 2009 274d
WATERLASE C100, MODEL 7100104
K091922 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2009 14d
EZLASE
K083595 · ILY Lamp, Infrared,... · Physical Medicine
Apr 2009 130d
WATERLASE MD
K090181 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2009 16d
EZLASE
K082938 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 2008 81d
EZLASE 10W
K083069 · GEX Powered Laser Surgical... · General & Plastic Surgery
Nov 2008 29d
WATERLASE, VERSION 3.0
K081589 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jun 2008 8d
WATERLASE AND WATERLASE MD
K071363 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2008 273d
WATERLASE MD DERM
K071734 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 2008 213d
EZLASE
K061898 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 2007 207d
OCULASE MD
K052354 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2006 310d
WATERLASE
K031140 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2004 454d
WATERLASE
K030523 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 2004 345d
LASERSMILE
K030539 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 2003 232d
WATERLASE FOR APICOECTOMY
K022803 · MXF System, Dental,... · Dental
Feb 2003 164d
WATERLASE MILLENNIUM
K013908 · MXF System, Dental,... · Dental
Feb 2002 78d
WATERLASE MILLENNIUM
K012511 · MXF System, Dental,... · Dental
Jan 2002 165d
WATERLASE, MILLENNIUM
K011041 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2001 89d
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