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RA-308 Excimer Laser System, Excimer Laser Catheter

by Ra Medical Systems, Inc

510(k) K170349

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170349 Date24 May 2017ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-0569-2021 FDA Class II initiated 16 Oct 2020

    Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.

    • Terminated Z-0050-2021 FDA Class II initiated 24 Jul 2020

    Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.

    • Terminated Z-2497-2020 FDA Class II initiated 23 Jan 2020

    A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.

    • Terminated Z-2006-2020 FDA Class II initiated 19 Sep 2019

    The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.

    • Terminated Z-2218-2019 FDA Class II initiated 15 Feb 2018

    Lasers/Catheters did not calibrate during set-up prior to use.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RA-308 Excimer Laser System is a catheter for crossing total occlusions, utilizing excimer laser technology to fragment atherosclerotic plaque within coronary arteries. This device combines a reusable laser light source with a single-use, e-beam sterilized catheter designed to restore blood flow in severely obstructed vessels. Its primary function is to mechanically disrupt calcified or fibrous lesions that cannot be traversed by conventional angioplasty or guidewire techniques. The system operates under Class II regulatory classification, adhering to FDA-substantiated equivalence standards for cardiovascular interventions.

The device is supplied as a combination of a reusable laser console and disposable catheters, intended for use in cardiac catheterization laboratories under fluoroscopic guidance. Each catheter is single-use, sterilized via electron beam irradiation, and compatible with standard coronary angiography equipment. The system is non-MRI-safe and requires proper storage in a clean, dry environment to maintain sterility and functionality. Authorized for commercial distribution in the United States via FDA 510(k) clearance (K170349), it is regulated under the Catheter for Crossing Total Occlusions product code (PDU) and falls under the 870.1250 classification for excimer laser devices.

Other devices from Ra Medical Systems, Inc

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RA-308 Excimer Laser Catheter designed to treat?

    The RA-308 Excimer Laser Catheter is specifically designed to mechanically disrupt calcified or fibrous lesions in coronary arteries that cannot be crossed using standard angioplasty or guidewire techniques. It employs excimer laser technology to fragment atherosclerotic plaque, helping to restore blood flow in severely obstructed vessels.

  • How is the RA-308 Excimer Laser System supplied, and what components are included?

    The RA-308 Excimer Laser System is supplied as a combination of a reusable laser console and single-use, e-beam sterilized catheters. The system is intended for use in cardiac catheterization laboratories under fluoroscopic guidance and is compatible with standard coronary angiography equipment.

  • Is the catheter single-use or reusable, and how is it sterilized?

    The RA-308 Excimer Laser Catheter is designed for single-use only. Each catheter is sterilized using electron beam irradiation (e-beam sterilization) to ensure sterility and safety for one-time clinical use.

  • What storage conditions are required to maintain the catheter’s functionality and sterility?

    The RA-308 Excimer Laser Catheter must be stored in a clean, dry environment to preserve its sterility and functionality. Proper storage conditions are critical to ensure the device remains effective for its intended use.

  • Is the RA-308 Excimer Laser System MRI-safe?

    No, the RA-308 Excimer Laser System is not MRI-safe. This means it should not be used or stored in an MRI environment, as it could interfere with MRI imaging or pose risks during the procedure.