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FDA 510(k)

MIRA LASERS

K-Number: K123004 · 2013-01-15

ApplicantMira Lasers, LLC
Decision Date2013-01-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIRA LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Mira Lasers, LLC. It received FDA 510(k) clearance on 2013-01-15 under 510(k) number K123004. 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 MIRA LASERS?

MIRA LASERS is a medical device that received FDA 510(k) clearance on 2013-01-15. The listed applicant is Mira Lasers, LLC. The 510(k) number is K123004.

When did MIRA LASERS receive FDA 510(k) clearance?

MIRA LASERS received FDA 510(k) clearance on 2013-01-15, under 510(k) number K123004.

Who is the listed applicant for MIRA LASERS?

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

What is the FDA product code for MIRA LASERS?

The FDA product code for MIRA LASERS is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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