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FDA 510(k)

LASERSCOPE'S MICROSPOT DERMASTAT

K-Number: K914918 · 1992-07-24

ApplicantLaserscope
Decision Date1992-07-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSCOPE'S MICROSPOT DERMASTAT is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1992-07-24 under 510(k) number K914918. 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 LASERSCOPE'S MICROSPOT DERMASTAT?

LASERSCOPE'S MICROSPOT DERMASTAT is a medical device that received FDA 510(k) clearance on 1992-07-24. The listed applicant is Laserscope. The 510(k) number is K914918.

When did LASERSCOPE'S MICROSPOT DERMASTAT receive FDA 510(k) clearance?

LASERSCOPE'S MICROSPOT DERMASTAT received FDA 510(k) clearance on 1992-07-24, under 510(k) number K914918.

Who is the listed applicant for LASERSCOPE'S MICROSPOT DERMASTAT?

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

What is the FDA product code for LASERSCOPE'S MICROSPOT DERMASTAT?

The FDA product code for LASERSCOPE'S MICROSPOT DERMASTAT is GEX. This falls under the Gastroenterology category.

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Other records listing Laserscope 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.

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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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