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FDA 510(k)

LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER

K-Number: K871206 · 1987-07-22

ApplicantPhase-R Corp.
Decision Date1987-07-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Phase-R Corp.. It received FDA 510(k) clearance on 1987-07-22 under 510(k) number K871206. 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 LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER?

LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER is a medical device that received FDA 510(k) clearance on 1987-07-22. The listed applicant is Phase-R Corp.. The 510(k) number is K871206.

When did LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER receive FDA 510(k) clearance?

LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER received FDA 510(k) clearance on 1987-07-22, under 510(k) number K871206.

Who is the listed applicant for LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER?

The FDA 510(k) record lists Phase-R Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER?

The FDA product code for LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER is GEX. This falls under the Gastroenterology category.

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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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