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FDA 510(k)

MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60

K-Number: K013864 · 2002-02-08

ApplicantNidek, Inc.
Decision Date2002-02-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 2002-02-08 under 510(k) number K013864. 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 MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60?

MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 is a medical device that received FDA 510(k) clearance on 2002-02-08. The listed applicant is Nidek, Inc.. The 510(k) number is K013864.

When did MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 receive FDA 510(k) clearance?

MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 received FDA 510(k) clearance on 2002-02-08, under 510(k) number K013864.

Who is the listed applicant for MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60?

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

What is the FDA product code for MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60?

The FDA product code for MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 is GEX. This falls under the Gastroenterology category.

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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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