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FDA 510(k)

SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)

K-Number: K973354 · 1997-12-04

ApplicantSharplan Lasers, Inc.
Decision Date1997-12-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) 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 1997-12-04 under 510(k) number K973354. 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 EPITOUCH ALEXANDRITE LASER SYSTEM (5000)?

SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K973354.

When did SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) receive FDA 510(k) clearance?

SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) received FDA 510(k) clearance on 1997-12-04, under 510(k) number K973354.

Who is the listed applicant for SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)?

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 EPITOUCH ALEXANDRITE LASER SYSTEM (5000)?

The FDA product code for SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) 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.

K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMK971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K971648SHARPLAN ERBIUM: YAG LASER (4020)K971743SHARPLAN CO2 SURGICAL LASER SYSTEMK962446SHARPLAN RUBY LASER SYSTEMK963229SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS

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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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