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FDA 510(k)

SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749

K-Number: K890059 · 1989-02-06

ApplicantSharplan Lasers, Inc.
Decision Date1989-02-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Lasers, Inc.. It received FDA 510(k) clearance on 1989-02-06 under 510(k) number K890059. 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 COMBINED CO2/ND:YAG LASER MICRO. #749?

SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 is a medical device that received FDA 510(k) clearance on 1989-02-06. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K890059.

When did SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 receive FDA 510(k) clearance?

SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 received FDA 510(k) clearance on 1989-02-06, under 510(k) number K890059.

Who is the listed applicant for SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749?

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

What is the FDA product code for SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749?

The FDA product code for SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 is GEX. This falls under the Gastroenterology category.

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Other records listing Sharplan 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.

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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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