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FDA 510(k)

PHAROS EXCIMER LASER SYSTEM, MODEL EX-308

K-Number: K062963 · 2007-04-03

ApplicantRa Medical Systems,Inc
Decision Date2007-04-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 is the device name listed in this FDA 510(k) record. The listed applicant is Ra Medical Systems,Inc. It received FDA 510(k) clearance on 2007-04-03 under 510(k) number K062963. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHAROS EXCIMER LASER SYSTEM, MODEL EX-308?

PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 is a medical device that received FDA 510(k) clearance on 2007-04-03. The listed applicant is Ra Medical Systems,Inc. The 510(k) number is K062963.

When did PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 receive FDA 510(k) clearance?

PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 received FDA 510(k) clearance on 2007-04-03, under 510(k) number K062963.

Who is the listed applicant for PHAROS EXCIMER LASER SYSTEM, MODEL EX-308?

The FDA 510(k) record lists Ra Medical Systems,Inc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHAROS EXCIMER LASER SYSTEM, MODEL EX-308?

The FDA product code for PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 is GEX. This falls under the Gastroenterology category.

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Other records listing Ra Medical Systems,Inc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)K170349RA-308 Excimer Laser System, Excimer Laser Catheter

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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.

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