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FDA 510(k)

PHOTEX30 DIODE LASER SERIES: 980, 810, 940

K-Number: K092197 · 2009-10-06

ApplicantBiotex, Inc.
Decision Date2009-10-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOTEX30 DIODE LASER SERIES: 980, 810, 940 is the device name listed in this FDA 510(k) record. The listed applicant is Biotex, Inc.. It received FDA 510(k) clearance on 2009-10-06 under 510(k) number K092197. 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 PHOTEX30 DIODE LASER SERIES: 980, 810, 940?

PHOTEX30 DIODE LASER SERIES: 980, 810, 940 is a medical device that received FDA 510(k) clearance on 2009-10-06. The listed applicant is Biotex, Inc.. The 510(k) number is K092197.

When did PHOTEX30 DIODE LASER SERIES: 980, 810, 940 receive FDA 510(k) clearance?

PHOTEX30 DIODE LASER SERIES: 980, 810, 940 received FDA 510(k) clearance on 2009-10-06, under 510(k) number K092197.

Who is the listed applicant for PHOTEX30 DIODE LASER SERIES: 980, 810, 940?

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

What is the FDA product code for PHOTEX30 DIODE LASER SERIES: 980, 810, 940?

The FDA product code for PHOTEX30 DIODE LASER SERIES: 980, 810, 940 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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