LaserSmile

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

510(k) Number

K030539 ↗

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 LaserSmile device used for in refractive surgery?

  The LaserSmile device is designed for laser-assisted corneal flap procedures, enabling precise creation of thin corneal flaps without a microkeratome. This allows surgeons to perform refractive surgeries like photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK) to correct vision issues such as myopia (nearsightedness), hyperopia (farsightedness), and astigmatism. The femtosecond laser ensures accuracy and consistency in flap creation, improving outcomes for patients.

• Is the LaserSmile device single-use or reusable?

  The LaserSmile device is supplied as a sterile, single-use medical device. This design ensures patient safety by eliminating the risk of cross-contamination between procedures, which is critical in sterile surgical environments like ophthalmology clinics or hospitals. Single-use devices also reduce the need for reprocessing and maintenance, streamlining workflow for clinical staff.

• What storage and handling requirements apply to the LaserSmile device?

  The LaserSmile device must be stored and handled according to sterile instrument protocols to maintain its integrity and sterility. Since it is single-use, it should be kept in its original packaging until immediately before use, in a clean, dry environment protected from contamination. Proper storage ensures the device remains functional and safe for the intended surgical procedure, adhering to manufacturer guidelines for optimal performance.

• Does the LaserSmile device have any special considerations for MRI safety?

  Yes, the LaserSmile device is designed with non-ferromagnetic components, which means it is safe for use in environments where MRI scans may be performed on patients. However, the device itself should not be exposed to MRI fields during operation, as this could potentially affect its performance or safety. Surgeons and staff should follow manufacturer guidelines to ensure proper handling and usage, particularly in facilities where MRI compatibility is a concern.

• Where can the LaserSmile device be used, and what environment is required?

  The LaserSmile device is intended for use in clean surgical environments such as ophthalmology clinics or hospitals. It requires a controlled setting where sterile procedures are performed, as it is a medical device used directly on the eye. Proper calibration and adherence to manufacturer guidelines are essential for safe operation, including ensuring the device is used by trained surgeons familiar with its application in refractive surgery.