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FDA 510(k)

POLARIS DIODE LASER SYSTEM AND ACCESSORIES

K-Number: K990914 · 1999-07-30

ApplicantXintec Corporation
Decision Date1999-07-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLARIS DIODE LASER SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Xintec Corporation. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K990914. 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 POLARIS DIODE LASER SYSTEM AND ACCESSORIES?

POLARIS DIODE LASER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Xintec Corporation. The 510(k) number is K990914.

When did POLARIS DIODE LASER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

POLARIS DIODE LASER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 1999-07-30, under 510(k) number K990914.

Who is the listed applicant for POLARIS DIODE LASER SYSTEM AND ACCESSORIES?

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

What is the FDA product code for POLARIS DIODE LASER SYSTEM AND ACCESSORIES?

The FDA product code for POLARIS DIODE LASER SYSTEM AND ACCESSORIES 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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