510(k) Report

FDA applicant

Ra Medical Systems,Inc

Carlsbad, CA4 decisions2007–20227 recalls

FDA records 4 decisions for Ra Medical Systems,Inc (Carlsbad, CA) from 2007 to 2022: 4 510(k) clearances. Most are in product codes PDU (Catheter For Crossing Total Occlusions) and GEX (Powered Laser Surgical Instrument). Its devices cite 16 predicates, 2 of them its own earlier devices. 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ra Medical Systems,Inc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12017: 12021: 12022: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2020

2014: 12018: 12019: 22020: 3
2007high 3 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ra Medical Systems,Inc by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ra Medical Systems,Inc’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PDUCatheter For Crossing Total Occlusions3decisions
  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 16 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc · 20171cites it
  • K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc · 20211cites it
  • K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 20071cites it

What has FDA decided for it lately?

  • K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc · 2022
  • K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc · 2021
  • K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc · 20175 recalls
  • K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 20072 recalls

All 4 as Ra Medical Systems,Inc →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K170349DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in…Oct 16, 2020Class II
  • K170349DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use…Jul 24, 2020Class II
  • K170349DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer…Jan 23, 2020Class II
  • K170349Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE…Sep 19, 2019Class II
  • K062963Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser…Aug 23, 2019Class II
  • K170349The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy…Feb 15, 2018Class II