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FDA 510(k)

SHARPLAN LASERS, INC. RUBY LASER SYSTEM

K-Number: K961279 · 1996-06-18

ApplicantSharplan Lasers, Inc.
Decision Date1996-06-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN LASERS, INC. RUBY LASER SYSTEM 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 1996-06-18 under 510(k) number K961279. 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 LASERS, INC. RUBY LASER SYSTEM?

SHARPLAN LASERS, INC. RUBY LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-18. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K961279.

When did SHARPLAN LASERS, INC. RUBY LASER SYSTEM receive FDA 510(k) clearance?

SHARPLAN LASERS, INC. RUBY LASER SYSTEM received FDA 510(k) clearance on 1996-06-18, under 510(k) number K961279.

Who is the listed applicant for SHARPLAN LASERS, INC. RUBY LASER SYSTEM?

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 LASERS, INC. RUBY LASER SYSTEM?

The FDA product code for SHARPLAN LASERS, INC. RUBY LASER SYSTEM 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.

K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K972099SHARPLAN EPITOUCH RUBY LASER SYSTEMK971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)K971648SHARPLAN ERBIUM: YAG LASER (4020)K971743SHARPLAN CO2 SURGICAL LASER SYSTEMK962446SHARPLAN RUBY LASER SYSTEM

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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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