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FDA 510(k)

PIONEER ELITE DIODE LASER

K-Number: K131059 · 2013-09-13

ApplicantCAO Group, Inc.
Decision Date2013-09-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PIONEER ELITE DIODE LASER is the device name listed in this FDA 510(k) record. The listed applicant is CAO Group, Inc.. It received FDA 510(k) clearance on 2013-09-13 under 510(k) number K131059. 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 PIONEER ELITE DIODE LASER?

PIONEER ELITE DIODE LASER is a medical device that received FDA 510(k) clearance on 2013-09-13. The listed applicant is CAO Group, Inc.. The 510(k) number is K131059.

When did PIONEER ELITE DIODE LASER receive FDA 510(k) clearance?

PIONEER ELITE DIODE LASER received FDA 510(k) clearance on 2013-09-13, under 510(k) number K131059.

Who is the listed applicant for PIONEER ELITE DIODE LASER?

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

What is the FDA product code for PIONEER ELITE DIODE LASER?

The FDA product code for PIONEER ELITE DIODE LASER is GEX. This falls under the Gastroenterology category.

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Other records listing CAO Group, 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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