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FDA 510(k)

AURORA M MEDICAL DYE LASER

K-Number: K855246 · 1986-03-21

ApplicantCooper Lasersonics, Inc.
Decision Date1986-03-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AURORA M MEDICAL DYE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1986-03-21 under 510(k) number K855246. 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 AURORA M MEDICAL DYE LASER?

AURORA M MEDICAL DYE LASER is a medical device that received FDA 510(k) clearance on 1986-03-21. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K855246.

When did AURORA M MEDICAL DYE LASER receive FDA 510(k) clearance?

AURORA M MEDICAL DYE LASER received FDA 510(k) clearance on 1986-03-21, under 510(k) number K855246.

Who is the listed applicant for AURORA M MEDICAL DYE LASER?

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

What is the FDA product code for AURORA M MEDICAL DYE LASER?

The FDA product code for AURORA M MEDICAL DYE LASER 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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