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FDA 510(k)

UNIPULSE CO2 SURGICAL LASER SYSTEM

K-Number: K980475 · 1998-12-16

ApplicantNidek, Inc.
Decision Date1998-12-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIPULSE CO2 SURGICAL 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 1998-12-16 under 510(k) number K980475. 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 UNIPULSE CO2 SURGICAL LASER SYSTEM?

UNIPULSE CO2 SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Nidek, Inc.. The 510(k) number is K980475.

When did UNIPULSE CO2 SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

UNIPULSE CO2 SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1998-12-16, under 510(k) number K980475.

Who is the listed applicant for UNIPULSE CO2 SURGICAL 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 UNIPULSE CO2 SURGICAL LASER SYSTEM?

The FDA product code for UNIPULSE CO2 SURGICAL 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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