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FDA 510(k)

LASER SYSTEM, SHARPLAN 791/HE, CO2

K-Number: K782030 · 1979-01-22

ApplicantLaser Industries , Ltd.
Decision Date1979-01-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER SYSTEM, SHARPLAN 791/HE, CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Industries , Ltd.. It received FDA 510(k) clearance on 1979-01-22 under 510(k) number K782030. 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 LASER SYSTEM, SHARPLAN 791/HE, CO2?

LASER SYSTEM, SHARPLAN 791/HE, CO2 is a medical device that received FDA 510(k) clearance on 1979-01-22. The listed applicant is Laser Industries , Ltd.. The 510(k) number is K782030.

When did LASER SYSTEM, SHARPLAN 791/HE, CO2 receive FDA 510(k) clearance?

LASER SYSTEM, SHARPLAN 791/HE, CO2 received FDA 510(k) clearance on 1979-01-22, under 510(k) number K782030.

Who is the listed applicant for LASER SYSTEM, SHARPLAN 791/HE, CO2?

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

What is the FDA product code for LASER SYSTEM, SHARPLAN 791/HE, CO2?

The FDA product code for LASER SYSTEM, SHARPLAN 791/HE, CO2 is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Industries , Ltd. 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.

K933362SHARPLAN CO2 SURGICAL LASERK894765SHARPLAN SMOKE EVACUATION UNIT, MODEL 100K850633SHARPLAN MODEL 1060 CO/2 SURGICAL LASERK850628SHARPLAN 1040 CO/2 SURGICAL LASERK842997LASER RECTOSCOPE SET 784K832550SHARPLAN #734 LASER SURGICAL UNIT

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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

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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