Twilight

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K991994 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Waterlase C100, Model 7100104

  Class II

  FDA 510(k) K091922 Active Cleared 14 Jul 2009

• Waterlase Iplus All Tissue Laser

  Class II

  FDA 510(k) K122368 Active Cleared 2 May 2013

• Millennium

  Class I

  FDA 510(k) K980585 Active Cleared 8 Oct 1998

• Modification of Millennium

  Class II

  FDA 510(k) K990219 Active Cleared 24 Feb 1999

• Lazersmile, Lazerwhite

  Class I

  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 Twilight laser device used for?

  The Twilight laser device is used to incise, excise and ablate intraoral soft tissues safely and effectively in general and plastic surgery procedures, utilizing optical energy from a Gallium Aluminum Arsenide (GaAlAs) solid state laser diode.

• How is the Twilight laser device supplied and by whom?

  The Twilight laser device is supplied by Biolase Technology, Inc., as indicated in the manufacturer and applicant fields of its FDA 510(k) clearance documentation.

• What regulatory pathway was used to authorize the Twilight laser device in the United States?

  The Twilight laser device was cleared through the FDA 510(k) process under submission K991994, with a decision of substantially equivalent and product code GEX, classifying it as a Class II medical device for use in the United States.