Waterlase MD Turbo Plus Model 7200XXX

• • Terminated Z-2263-2014 FDA Class II ·initiated 12 Jun 2014

  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.

510(k) Number

K101658 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K091922 Active Cleared 14 Jul 2009

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  Class II

  FDA 510(k) K122368 Active Cleared 2 May 2013

• Millennium

  Class I

  FDA 510(k) K980585 Active Cleared 8 Oct 1998

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  FDA 510(k) K990219 Active Cleared 24 Feb 1999

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  FDA 510(k) K000290 Active Cleared 14 Apr 2000

• Oculase Md

  Class II

  FDA 510(k) K052354 Active Cleared 5 Jul 2006

See all devices from Biolase Technology, Inc. →

• What is the Waterlase MD Turbo Plus used for?

  The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, and removal of tissue, as well as specific dental therapies including root canal therapy and periodontal therapy.

• How is the Waterlase MD Turbo Plus supplied?

  The device is supplied by Biolase Technology, Inc. and has received FDA 510(k) clearance with the product code GEX. It is intended for use in dental procedures and has been cleared for various indications by regulatory authorities.

• What technology does the Waterlase MD Turbo Plus utilize?

  The Waterlase MD Turbo Plus utilizes a combination of YSGG laser technology and water spray for tissue cutting, providing a unique approach to dental procedures.

• What is the regulatory status of the Waterlase MD Turbo Plus?

  The Waterlase MD Turbo Plus has received FDA 510(k) clearance with the product code GEX and is intended for use in dental procedures. It has been cleared for various indications by regulatory authorities.