XTRAC Excimer Laser System, Model AL 7000

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

510(k) Number

K011382 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Laserpro Diode Laser Systems, Models 810, 940 & 980

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  FDA 510(k) K040294 Active Cleared 5 May 2004

• Laserpro 810, 940 and 980 Diode Laser Systems

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• Xtrac Ultra 2, Model AL10000

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• Xtracxl Plus Excimer Laser System, Model AL7000

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• Xtrac Excimer Laser System, Model AL7000

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• Laserpro CO2 Carbon Dioxide Laser System

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See all devices from Photo Medex, Inc. →

• What is the XTRAC Excimer Laser System, Model AL 7000 used for?

  The XTRAC Excimer Laser System, Model AL 7000 is designed for excimer laser therapy, specifically delivering ultraviolet B (UVB) phototherapy. This non-invasive treatment targets specific skin conditions where UVB therapy has been proven safe and effective, such as vitiligo, psoriasis, or other dermatological disorders. It operates under FDA clearance for general and plastic surgery applications, ensuring its use aligns with established clinical guidelines for dermatological interventions.

• Is the XTRAC Excimer Laser System, Model AL 7000 reusable or single-use?

  The XTRAC Excimer Laser System, Model AL 7000 is supplied as a reusable medical instrument. As a reusable device, it must undergo proper maintenance, cleaning, and sterilization procedures as outlined by the manufacturer to ensure safety, functionality, and compliance with regulatory standards. Regular upkeep is critical to prevent contamination and maintain performance for clinical use.

• What regulatory approval does the XTRAC Excimer Laser System, Model AL 7000 hold?

  The XTRAC Excimer Laser System, Model AL 7000 holds FDA 510(k) clearance under the reference number K011382. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and falls under the product code GEX for powered laser surgical instruments. The system is classified under general and plastic surgery applications, adhering to regulatory standards for laser-based dermatological treatments.

• How should the XTRAC Excimer Laser System, Model AL 7000 be stored?

  The XTRAC Excimer Laser System, Model AL 7000 should be stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and moisture. Storage should comply with manufacturer guidelines to prevent damage to the laser components and ensure longevity. Additionally, the system must be stored in accordance with regulatory and clinical standards for reusable medical devices, including proper handling and maintenance protocols to maintain sterility and operational readiness.

• What maintenance is required for the XTRAC Excimer Laser System, Model AL 7000?

  The XTRAC Excimer Laser System, Model AL 7000 requires adherence to the manufacturer’s maintenance guidelines to ensure safe and effective operation. This includes regular cleaning, calibration, and servicing of the laser components, as well as proper sterilization procedures before each use. Maintenance logs should be kept to document all servicing activities, ensuring compliance with regulatory requirements and clinical best practices for laser surgical instruments.