Flexiguide CO2 Laser Hollow Flexible Fiber

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

Full name

Flexiguide(Tm) CO2 Laser Hollow Flexible Fiber

510(k) Number

K900066 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Modified Endoguide

  Class II

  FDA 510(k) K895559 Active Cleared 20 Oct 1989

• Endoguide (R), Microguide (Tm), Flexiguide (Tm)

  Class II

  FDA 510(k) K903079 Active Cleared 4 Oct 1990

• Luxar Model LX-20 Minilase CO2 Laser

  Class II

  FDA 510(k) K896478 Active Cleared 8 Feb 1990

• Luxar Model Lx-20 CO2 Laser

  Class II

  FDA 510(k) K904068 Active Cleared 15 Apr 1991

• Luxar Endoguide CO2 Laser Waveguide

  Class II

  FDA 510(k) K884459 Active Cleared 19 Dec 1988

• Listing Podiatry As Intended Use for Endoguide

  Class II

  FDA 510(k) K896711 Active Cleared 9 Jan 1990

See all devices from Luxar Corp. →

• What is the Flexiguide CO2 Laser Hollow Flexible Fiber used for?

  The Flexiguide CO2 Laser Hollow Flexible Fiber is designed for precise laser tissue ablation in surgical procedures. Its flexible, hollow construction allows targeted energy delivery in confined or delicate anatomical areas, reducing collateral thermal damage. This makes it particularly useful in general and plastic surgery applications where precision and minimal tissue disruption are critical.

• Is the Flexiguide CO2 Laser Hollow Flexible Fiber single-use or reusable?

  This device is supplied as a reusable medical instrument. It requires proper sterilization between uses to maintain safety and functionality. Sterilization protocols must align with standard surgical laser safety guidelines to ensure operational integrity and patient safety.

• Can the Flexiguide CO2 Laser Hollow Flexible Fiber be used in MRI environments?

  No, the Flexiguide CO2 Laser Hollow Flexible Fiber is intended for use in MRI-unsafe environments. This is due to its laser components, which are incompatible with MRI systems. Always verify the surgical environment’s safety protocols before use.

• What safety considerations are important when storing or handling this device?

  Storage and handling must comply with standard surgical laser safety protocols to preserve the device’s operational integrity and ensure patient safety. Since it is reusable, proper sterilization between uses is mandatory. Additionally, avoid exposure to conditions that could compromise the fiber’s flexibility or laser delivery system.

• What regulatory clearance does the Flexiguide CO2 Laser Hollow Flexible Fiber hold?

  The device holds an FDA 510(k) clearance (K900066) under the Traditional clearance type, classified as Substantially Equivalent (SESE) to a predicate device. This clearance confirms its compliance with FDA standards for general and plastic surgery applications.