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FDA 510(k)

SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS

K-Number: K913037 · 1991-09-06

ApplicantSharplan Lasers, Inc.
Decision Date1991-09-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS 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 1991-09-06 under 510(k) number K913037. 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 SHARPLASE FAMILY ND:YAG SCULPTED FIBERS?

SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Sharplan Lasers, Inc.. The 510(k) number is K913037.

When did SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS receive FDA 510(k) clearance?

SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS received FDA 510(k) clearance on 1991-09-06, under 510(k) number K913037.

Who is the listed applicant for SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS?

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 SHARPLASE FAMILY ND:YAG SCULPTED FIBERS?

The FDA product code for SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS is GEX. This falls under the Gastroenterology category.

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Other records listing Sharplan Lasers, Inc. as applicant

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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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