DABRA Excimer Laser System (RA-308 and Catheter Model 2.0)

No FDA recalls found in the data synced 5 Oct 2026.

Full name

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

510(k) Number

K220544 ↗

FDA Product Code

PDU

FDA applicant

Ra Medical Systems,Inc

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pharos Excimer Laser System, Model Ex-308

  Class II

  FDA 510(k) K062963 Active Cleared 3 Apr 2007

• DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

  Class II

  FDA 510(k) K210664 Active Cleared 27 Jul 2021

• RA-308 Excimer Laser System, Excimer Laser Catheter

  Class II

  FDA 510(k) K170349 Active Cleared 24 May 2017

• What is the Dabra Excimer Laser System designed to treat?

  The Dabra Excimer Laser System is specifically designed to facilitate the recanalization of chronic total occlusions (CTOs) in coronary or peripheral arteries. It uses high-energy ultraviolet laser pulses delivered through a catheter to ablate calcified or fibrous plaque, enabling precise tissue removal while minimizing damage to surrounding vascular structures. This makes it particularly useful for cases where traditional angioplasty or stenting may be challenging due to severe blockages.

• How is the Dabra Excimer Laser System supplied, and what are its sterility requirements?

  The Dabra Excimer Laser System is supplied as a kit containing the reusable laser console (model RA-308) and single-use catheters (model 2.0). The laser console requires e-beam sterilization before use, while the catheters are pre-sterilized and intended for single-use only. This design ensures sterility and safety for each procedure, as the catheter is discarded after use.

• Is the Dabra Excimer Laser System reusable or single-use, and how does this affect its use?

  The Dabra Excimer Laser System consists of two components with different reuse policies: the laser console (RA-308) is reusable and requires e-beam sterilization between uses, while the catheter (model 2.0) is designed for single-use only. This distinction allows the laser console to be used across multiple procedures, while the catheter’s single-use nature ensures sterility and reduces the risk of contamination for each patient.

• What storage conditions are required for the Dabra Excimer Laser System?

  The Dabra Excimer Laser System must be stored in a protected environment to prevent exposure to moisture and extreme temperatures. Proper storage conditions are critical to maintaining the integrity of the laser console and catheters, ensuring optimal performance and sterility. Always follow manufacturer guidelines for storage to avoid compromising the device’s functionality or safety.

• What regulatory pathway does the Dabra Excimer Laser System follow, and what does this mean for clinicians?

  The Dabra Excimer Laser System holds FDA 510(k) clearance, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance is part of the traditional regulatory pathway, meaning it has undergone review by the FDA’s Cardiovascular Advisory Committee. Clinicians can rely on this clearance as evidence of the device’s safety and effectiveness for its intended use in recanalizing CTOs, though they should always follow local guidelines and institutional protocols.