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FDA 510(k)

ISL QC 2000 LASER

K-Number: K941694 · 1994-05-12

ApplicantIntelligent Surgical Lasers, Inc.
Decision Date1994-05-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISL QC 2000 LASER is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Surgical Lasers, Inc.. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K941694. 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 ISL QC 2000 LASER?

ISL QC 2000 LASER is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Intelligent Surgical Lasers, Inc.. The 510(k) number is K941694.

When did ISL QC 2000 LASER receive FDA 510(k) clearance?

ISL QC 2000 LASER received FDA 510(k) clearance on 1994-05-12, under 510(k) number K941694.

Who is the listed applicant for ISL QC 2000 LASER?

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

What is the FDA product code for ISL QC 2000 LASER?

The FDA product code for ISL QC 2000 LASER 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 Intelligent Surgical Lasers, 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.

K892058ISL QC 2000

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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