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FDA 510(k)

SHARPLAN 1040 CO/2 SURGICAL LASER

K-Number: K850628 · 1985-08-07

ApplicantLaser Industries , Ltd.
Decision Date1985-08-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN 1040 CO/2 SURGICAL LASER 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 1985-08-07 under 510(k) number K850628. 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 SHARPLAN 1040 CO/2 SURGICAL LASER?

SHARPLAN 1040 CO/2 SURGICAL LASER is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Laser Industries , Ltd.. The 510(k) number is K850628.

When did SHARPLAN 1040 CO/2 SURGICAL LASER receive FDA 510(k) clearance?

SHARPLAN 1040 CO/2 SURGICAL LASER received FDA 510(k) clearance on 1985-08-07, under 510(k) number K850628.

Who is the listed applicant for SHARPLAN 1040 CO/2 SURGICAL LASER?

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 SHARPLAN 1040 CO/2 SURGICAL LASER?

The FDA product code for SHARPLAN 1040 CO/2 SURGICAL LASER 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 LASERK842997LASER RECTOSCOPE SET 784K832550SHARPLAN #734 LASER SURGICAL UNITK832551SHARPLAN #745 LASER SURG. 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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