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FDA 510(k)

LASE SYSTEM II

K-Number: K871334 · 1987-06-01

ApplicantLase, Inc.
Decision Date1987-06-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASE SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Lase, Inc.. It received FDA 510(k) clearance on 1987-06-01 under 510(k) number K871334. 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 LASE SYSTEM II?

LASE SYSTEM II is a medical device that received FDA 510(k) clearance on 1987-06-01. The listed applicant is Lase, Inc.. The 510(k) number is K871334.

When did LASE SYSTEM II receive FDA 510(k) clearance?

LASE SYSTEM II received FDA 510(k) clearance on 1987-06-01, under 510(k) number K871334.

Who is the listed applicant for LASE SYSTEM II?

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

What is the FDA product code for LASE SYSTEM II?

The FDA product code for LASE SYSTEM II 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.

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Other records listing Lase, 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.

K922555ENVIROMATE(TM) SMOKE EVACUATION SYSTEMK874157LASE EVACUATOR/ASPIRATOR

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.

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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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