Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:YAG Configuration)

• • Terminated Z-1229-2011 FDA Unclassified (pre-2012) ·initiated 8 Feb 2010

  A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.

• • Terminated Z-0131-2008 FDA Unclassified (pre-2012) ·initiated 18 Jun 2007

  Control knob break: The knob used to finely control the direction of the laser energy may break.

• • Terminated Z-0130-2008 FDA Unclassified (pre-2012) ·initiated 17 Apr 2007

  Component missing: Some products were issued without thermal protection switches.

510(k) Number

K010284 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ktp/532 & Ktp/Yag

  Class II

  FDA 510(k) K913990 Active Cleared 2 Sep 1992

• Ktp/Yag and Ktp/Yag Plus

  Class II

  FDA 510(k) K914518 Active Cleared 2 Apr 1992

• Ktp/532 and Ktp/Yag

  Class II

  FDA 510(k) K913758 Active Cleared 20 Nov 1991

• Ktp/532 Laser

  Class II

  FDA 510(k) K873330 Active Cleared 18 Nov 1987

• Ktp/532 Surgical Laser

  Class II

  FDA 510(k) K884029 Active Cleared 25 Nov 1988

• 800 Series Surgical Laser System and Acccessories

  Class II

  FDA 510(k) K970948 Active Cleared 21 May 1997

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• What types of surgical procedures is the Lyra G Series Surgical Laser System primarily used for?

  The Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:YAG) is designed for precise tissue ablation, coagulation, and treatment of vascular lesions, making it particularly useful in dermatology and plastic surgery. Its high-energy, short-duration pulses are ideal for procedures like tattoo removal, pigmented lesion treatment, and vascular lesion management, where controlled energy delivery is critical.

• Is the Lyra G Series Surgical Laser System reusable, and if so, what sterilization process should be followed?

  Yes, the Lyra G Series Surgical Laser System is a reusable medical device. Since it is not sterile upon delivery, it must undergo sterilization prior to use following standard surgical laser safety protocols. The manufacturer’s instructions should be strictly adhered to for proper sterilization, storage, and maintenance to ensure safety and functionality in controlled clinical settings like operating rooms.

• How is the Lyra G Series Surgical Laser System regulated, and what does its FDA clearance indicate?

  The Lyra G Series Surgical Laser System holds FDA 510(k) clearance under the classification of General, Plastic Surgery (reviewed by the Surgical Devices Subcommittee). The clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate, meaning it meets regulatory standards for safety and effectiveness as determined by the FDA. This classification reflects its intended use in surgical applications, particularly in dermatology and plastic surgery.

• What safety protocols should be followed when storing or maintaining this laser system?

  The Lyra G Series Surgical Laser System requires compliance with the manufacturer’s guidelines for storage, maintenance, and operational safety. Since it is reusable and not sterile upon delivery, proper sterilization procedures must be followed before use. Additionally, adherence to standard surgical laser safety protocols—such as proper handling, environmental controls, and regular equipment checks—is essential to prevent damage, ensure longevity, and maintain performance in clinical settings like operating rooms or surgical suites.