RA-308 Excimer Laser System, Excimer Laser Catheter— 510(k) K170349

Clearance details

Applicant

Ra Medical Systems,Inc

Product code

Code PDU

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2017-02-03

Decision date

2017-05-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

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• K251376 — LimFlow ARC2025-05-31
• K232562 — PowerWire Radiofrequency Guidewire Kit2024-02-28

• K220544 — DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)2022-06-29
• K210664 — DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)2021-07-27
• K062963 — PHAROS EXCIMER LASER SYSTEM, MODEL EX-3082007-04-03

Malfunction

793

Total

793

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0569-2021 — DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.Class II·Terminated·Ra Medical Systems, Inc.·20201016
• Z-0050-2021 — DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.Class II·Terminated·Ra Medical Systems, Inc.·20200724
• Z-2497-2020 — DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system.Class II·Terminated·Ra Medical Systems, Inc.·20200123
• Z-2006-2020 — Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY: 2019-12-13, MFR DATE: 2019-10-14, CE 2797, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Package Label - DABRA 101 5 French, Ref: 1222-5000-01, Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041Class II·Terminated·Ra Medical Systems, Inc.·20190919
• Z-2218-2019 — The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.Class II·Terminated·Ra Medical Systems Inc·20180215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170349.