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Biolase Technology, Inc.

United StatesFDA applicant, unverified

Devices
31
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Biolase Technology, Inc. makes

Biolase Technology, Inc. manufactures dental and medical lasers, including diode and IPL (Intense Pulsed Light) systems like the WaterLase C100 and WaterLase iPlus for soft tissue and hard tissue applications, as well as the Millennium and its modified versions for dental procedures. The company also produces the LazerSmile and LazerWhite for cosmetic dental treatments, the Oculase MD for ophthalmic use, and the EZLase for skin treatments. Additional offerings include the WaterLase MD for medical applications and the EPIC 10 and EZLase 10W for specific laser therapies.

These devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA 510(k) clearance database. The company is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue31

Newest first, rows 1-31 of 31

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  • Waterlase C100, Model 7100104 Ref K091922

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Iplus All Tissue Laser Ref K122368

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Millennium Ref K980585

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Modification Of Millennium Ref K990219

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lazersmile, Lazerwhite Ref K000290

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Oculase Md Ref K052354

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase, Millennium Ref K011041

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ezlase Ref K061898

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Md Ref K083927

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Ref K030523

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Epic 10 Ref K121286

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ezlase 10W Ref K083069

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Md Turbo Plus Model 7200XXX Ref K101658

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ezlase Ref K083595

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Ref K031140

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Diolase 10S Ref K121327

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Md Ref K090181

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Md, Model 7100102 Ref K091746

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase For Apicoectomy Ref K022803

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Millennium Ref K013908

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase And Waterlase Md Ref K071363

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Twilite, Twilite White Ref K003385

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Md Derm Ref K071734

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ezlase Ref K082938

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ezlase 3 Laser System Ref K093852

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lasersmile Ref K030539

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Epic 10S Ref K130465

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase, Version 3.0 Ref K081589

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Laserspray(Tm) Ref K950248

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Twilight Ref K991994

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Waterlase Millennium Ref K012511

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-31 of 31

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Biolase Technology, Inc., the earliest on 2005-01-17 and the most recent on 2014-06-12. By recorded status: 2 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2014

    • 12 Jun 2014 Z-2263-2014 Class II Terminated Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting will change to 1% and OFF. Distribution: Nationwide in US and worldwide to: Canada, UK, Russia, Korea, Hong Kong, Libya, Iran, Iraq, Kuwait, Singapore, Armenia,…
      Full distribution text Nationwide in US and worldwide to: Canada, UK, Russia, Korea, Hong Kong, Libya, Iran, Iraq, Kuwait, Singapore, Armenia, Egypt, Pakistan, Sweden, New Zealand, Poland, Germany, Italy, UAE.
      Submission number: K101658

  • 2005

    • 17 Jan 2005 Z-0543-05 Unclassified (pre-2012) Terminated Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation. Distribution: Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia,…
      Full distribution text Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan
      Submission number: K031140

Frequently asked questions

How many devices does Biolase Technology, Inc. have in the registry?

The registry currently lists 31 devices for Biolase Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biolase Technology, Inc.'s devices?

Among its 31 most recently registered devices, Biolase Technology, Inc. has devices listed in FDA 510(k) (31 devices).

What risk classes do Biolase Technology, Inc.'s devices fall under?

Among its 31 most recently registered devices, the classes recorded for Biolase Technology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Biolase Technology, Inc.?

FDA recall records list 2 recalls initiated by Biolase Technology, Inc., the most recent initiated on 12 Jun 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Biolase Technology, Inc. in the registry?

The most recently registered devices listed for Biolase Technology, Inc. include WATERLASE C100, MODEL 7100104, WATERLASE IPLUS ALL TISSUE LASER, MILLENNIUM and MODIFICATION OF MILLENNIUM.

Generated automatically from registry data and not verified by a human reviewer.