FDA 510(k)

RA-308 Excimer Laser System, Excimer Laser Catheter

K-Number: K170349 · 2017-05-24

Decision Date2017-05-24

Product CodePDU

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RA-308 Excimer Laser System, Excimer Laser Catheter is a medical device manufactured by Ra Medical Systems,Inc. It received FDA 510(k) clearance on 2017-05-24 under approval number K170349. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RA-308 Excimer Laser System, Excimer Laser Catheter?

RA-308 Excimer Laser System, Excimer Laser Catheter is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Ra Medical Systems,Inc. The 510(k) number is K170349.

When was RA-308 Excimer Laser System, Excimer Laser Catheter approved by the FDA?

RA-308 Excimer Laser System, Excimer Laser Catheter received FDA 510(k) clearance on 2017-05-24, under approval number K170349.

What company makes RA-308 Excimer Laser System, Excimer Laser Catheter?

RA-308 Excimer Laser System, Excimer Laser Catheter is manufactured by Ra Medical Systems,Inc.

What is the FDA product code for RA-308 Excimer Laser System, Excimer Laser Catheter?

The FDA product code for RA-308 Excimer Laser System, Excimer Laser Catheter is PDU.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Ra Medical Systems,Inc

K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.