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FDA 510(k)

COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS

K-Number: K895143 · 1989-09-25

ApplicantLumenis, Inc.
Decision Date1989-09-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1989-09-25 under 510(k) number K895143. 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 COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS?

COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS is a medical device that received FDA 510(k) clearance on 1989-09-25. The listed applicant is Lumenis, Inc.. The 510(k) number is K895143.

When did COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS receive FDA 510(k) clearance?

COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS received FDA 510(k) clearance on 1989-09-25, under 510(k) number K895143.

Who is the listed applicant for COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS?

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

What is the FDA product code for COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS?

The FDA product code for COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, Inc. as applicant

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Related Devices (Code: GEX)

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Official Source

View on FDA Database →

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

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