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FDA 510(k)

PILOT DIODE LASER, MODEL 002-00139

K-Number: K100143 · 2010-08-13

ApplicantCAO Group, Inc.
Decision Date2010-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PILOT DIODE LASER, MODEL 002-00139 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 2010-08-13 under 510(k) number K100143. 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 PILOT DIODE LASER, MODEL 002-00139?

PILOT DIODE LASER, MODEL 002-00139 is a medical device that received FDA 510(k) clearance on 2010-08-13. The listed applicant is CAO Group, Inc.. The 510(k) number is K100143.

When did PILOT DIODE LASER, MODEL 002-00139 receive FDA 510(k) clearance?

PILOT DIODE LASER, MODEL 002-00139 received FDA 510(k) clearance on 2010-08-13, under 510(k) number K100143.

Who is the listed applicant for PILOT DIODE LASER, MODEL 002-00139?

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 PILOT DIODE LASER, MODEL 002-00139?

The FDA product code for PILOT DIODE LASER, MODEL 002-00139 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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