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FDA 510(k)

TXCELL SCANNING LASER DELIVERY SYSTEM

K-Number: K121475 · 2012-11-28

ApplicantIridex Corp
Decision Date2012-11-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TXCELL SCANNING LASER DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corp. It received FDA 510(k) clearance on 2012-11-28 under 510(k) number K121475. 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 TXCELL SCANNING LASER DELIVERY SYSTEM?

TXCELL SCANNING LASER DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-28. The listed applicant is Iridex Corp. The 510(k) number is K121475.

When did TXCELL SCANNING LASER DELIVERY SYSTEM receive FDA 510(k) clearance?

TXCELL SCANNING LASER DELIVERY SYSTEM received FDA 510(k) clearance on 2012-11-28, under 510(k) number K121475.

Who is the listed applicant for TXCELL SCANNING LASER DELIVERY SYSTEM?

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

What is the FDA product code for TXCELL SCANNING LASER DELIVERY SYSTEM?

The FDA product code for TXCELL SCANNING LASER DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Iridex Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071687FAMILI OF IRIDEX IQ LASER SYSTEMSK062074IRIDEX WIRELESS FOOTSWITCHK062369IRIDEX OCULIGHT TXK060905IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1K050562OCULIGHT GL/GLXK040209IRIS MEDICAL IQ 810 PHOTOCOAGULATOR

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Related Devices (Code: GEX)

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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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