Fraxel Re:Pair (Fraxel III SR) Laser System and Accessories

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

510(k) Number

K080915 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Reliant Laser II System and Accessories

  Class II

  FDA 510(k) K042319 Active Cleared 10 Mar 2005

• Fralex Sr 1500 Laser System (Fralex II Sr Laser System)

  Class II

  FDA 510(k) K070284 Active Cleared 17 May 2007

• Fraxel III Sr Laser System and Accessories

  Class II

  FDA 510(k) K063038 Active Cleared 27 Apr 2007

• Unimax Model 2500 Multiwavelength Color Corrected

  Class II

  FDA 510(k) K943045 Active Cleared 13 Dec 1994

• Fraxel SR Laser System

  Class II

  FDA 510(k) K050841 Active Cleared 5 Jul 2005

• Reliant Laser System II

  Class II

  FDA 510(k) K040617 Active Cleared 15 Jun 2004

See all devices from Reliant Technologies, Inc. →

• What is the Fraxel Re:Pair (Fraxel III SR) Laser System used for?

  The Fraxel Re:Pair (Fraxel III SR) Laser System is designed for dermatological procedures, specifically for controlled ablation, resurfacing, and coagulation of soft tissue. Its fractional laser technology allows for selective tissue modification, making it ideal for skin rejuvenation, scar revision, and other targeted treatments while preserving surrounding dermal integrity. The system’s resurfacing handpiece enhances procedural accuracy and efficiency.

• How is the Fraxel Re:Pair Laser System supplied, and what does this mean for sterility?

  The Fraxel Re:Pair Laser System is supplied as a reusable laser instrument, but it includes disposable accessories such as handpieces and consumables to ensure sterility and patient safety. This design minimizes cross-contamination risks between patients, as only the single-use components come into direct contact with the patient during procedures.

• Is the Fraxel Re:Pair Laser System single-use or reusable, and what does this imply for clinical workflow?

  The Fraxel Re:Pair Laser System itself is reusable, meaning it can be used across multiple procedures after proper cleaning and maintenance. However, the handpieces and consumables are disposable, which ensures sterility and reduces the risk of infection. Clinicians must follow manufacturer guidelines for cleaning and reprocessing the reusable components to maintain functionality and compliance with clinical standards.

• What types of skin conditions can the Fraxel Re:Pair Laser System treat, and how does its fractional technology work?

  The Fraxel Re:Pair Laser System is primarily used for treating skin conditions requiring precise tissue modification, such as skin rejuvenation, scar revision, and pigmentation issues. Its fractional laser technology creates microscopic treatment zones within the skin, allowing for targeted ablation or coagulation while leaving surrounding tissue intact. This approach promotes natural healing and minimizes downtime compared to traditional resurfacing methods.

• Are there any special storage or handling requirements for the Fraxel Re:Pair Laser System?

  The Fraxel Re:Pair Laser System requires adherence to manufacturer guidelines for storage and handling to maintain functionality and sterility. While no specific MRI safety restrictions are noted, the reusable components must be cleaned and reprocessed according to established protocols to prevent contamination. Disposable accessories should be stored in a clean, dry environment until use, and the system should be operated only by trained personnel in controlled clinical settings.