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FDA 510(k)

DIO-LIGHT LASER SYSTEM

K-Number: K980201 · 1998-03-16

ApplicantNidek, Inc.
Decision Date1998-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIO-LIGHT LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1998-03-16 under 510(k) number K980201. 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 DIO-LIGHT LASER SYSTEM?

DIO-LIGHT LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-16. The listed applicant is Nidek, Inc.. The 510(k) number is K980201.

When did DIO-LIGHT LASER SYSTEM receive FDA 510(k) clearance?

DIO-LIGHT LASER SYSTEM received FDA 510(k) clearance on 1998-03-16, under 510(k) number K980201.

Who is the listed applicant for DIO-LIGHT LASER SYSTEM?

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 DIO-LIGHT LASER SYSTEM?

The FDA product code for DIO-LIGHT LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Nidek, Inc. as applicant

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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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