Crystalase 755 Laser System

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

Full name

Schwartz Electro-Optics, Inc. Crystalase 755 Laser System

510(k) Number

K973867 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium Laser

  Class II

  FDA 510(k) K953585 Active Cleared 5 Feb 1996

• Schwartz Electro-Optics, Inc. Crystalase 1064/532 Laser System

  Class II

  FDA 510(k) K973603 Active Cleared 19 Dec 1997

• Schwartz Electro-Optics, Inc. Clr 2940 Erbium Crystalase

  Class II

  FDA 510(k) K980313 Active Cleared 19 Mar 1998

• Trilase 2940 Erbium Laser

  Class II

  FDA 510(k) K954013 Active Cleared 31 Jan 1996

• Schwartz Electro-Optics, Inc. Clr 2940/Erbium Crystalase (Formerly Trilase 2940 Erbium Laser

  Class II

  FDA 510(k) K971404 Active Cleared 9 Jul 1997

• Schwartz Electro-Optics, Inc. Crystalase 755 Dp Alexandrite Laser System

  Class II

  FDA 510(k) K980710 Active Cleared 22 May 1998

See all devices from Schwartz Electro-Optics, Inc. →

• What is the Crystalase 755 Laser System used for?

  The Crystalase 755 Laser System is designed for dermatological procedures, specifically targeting pigmented tissues such as tattoos, epidermal lesions, and vascular abnormalities. It uses an Alexandrite laser emitting light at 755 nanometers to selectively apply photothermal effects, enabling controlled removal or alteration of targeted tissues. This makes it suitable for applications like tattoo removal, pigmentation correction, and treatment of vascular conditions in clinical settings.

• Is the Crystalase 755 Laser System single-use or reusable?

  The Crystalase 755 Laser System is a reusable medical device. It is intended for use in clinical environments like dermatology clinics or surgical facilities, where proper training and adherence to sterile protocols are required. Reusability allows for maintenance and calibration as specified by the manufacturer to ensure safety and operational integrity over multiple procedures.

• How should the Crystalase 755 Laser System be stored and maintained?

  Storage and maintenance of the Crystalase 755 Laser System must follow the manufacturer’s guidelines to preserve functionality and safety. This includes regular calibration and cleaning procedures tailored for laser instrumentation. Proper handling and adherence to these protocols are essential to prevent damage and ensure the device operates effectively for its intended dermatological applications.

• What regulatory approval does the Crystalase 755 Laser System hold?

  The Crystalase 755 Laser System holds FDA clearance under the 510(k) process, with clearance number K973867. The decision date was February 10, 1998, confirming its substantial equivalence to a predicate device. This clearance is specific to its classification under product code GEX for general and plastic surgery uses, ensuring it meets regulatory standards for powered laser surgical instruments.

• What wavelength does the Crystalase 755 Laser System emit, and why is this significant?

  The Crystalase 755 Laser System emits light at a wavelength of 755 nanometers, which is characteristic of an Alexandrite laser. This specific wavelength is significant because it allows for selective targeting of pigmented tissues, such as melanin in tattoos or blood vessels in vascular abnormalities. The photothermal effects at this wavelength enable precise and controlled tissue removal or alteration, minimizing damage to surrounding healthy tissue.