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FDA 510(k)

EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM

K-Number: K893956 · 1989-08-10

Decision Date1989-08-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM is the device name listed in this FDA 510(k) record. The listed applicant is Living Technology, Inc.. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K893956. 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 EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM?

EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Living Technology, Inc.. The 510(k) number is K893956.

When did EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM receive FDA 510(k) clearance?

EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM received FDA 510(k) clearance on 1989-08-10, under 510(k) number K893956.

Who is the listed applicant for EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM?

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

What is the FDA product code for EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM?

The FDA product code for EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

Other records listing Living Technology, 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.

Related Devices (Code: GEX)

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.

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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