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FDA 510(k)

PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940

K-Number: K060304 · 2006-03-21

ApplicantBiotex, Inc.
Decision Date2006-03-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 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 2006-03-21 under 510(k) number K060304. 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 PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940?

PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 is a medical device that received FDA 510(k) clearance on 2006-03-21. The listed applicant is Biotex, Inc.. The 510(k) number is K060304.

When did PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 receive FDA 510(k) clearance?

PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 received FDA 510(k) clearance on 2006-03-21, under 510(k) number K060304.

Who is the listed applicant for PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 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 PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940?

The FDA product code for PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 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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