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FDA 510(k)

AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS

K-Number: K081612 · 2008-06-25

ApplicantAesculight, LLC
Decision Date2008-06-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Aesculight, LLC. It received FDA 510(k) clearance on 2008-06-25 under 510(k) number K081612. 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 AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS?

AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS is a medical device that received FDA 510(k) clearance on 2008-06-25. The listed applicant is Aesculight, LLC. The 510(k) number is K081612.

When did AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS receive FDA 510(k) clearance?

AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS received FDA 510(k) clearance on 2008-06-25, under 510(k) number K081612.

Who is the listed applicant for AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS?

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

What is the FDA product code for AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS?

The FDA product code for AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS is GEX. This falls under the Gastroenterology category.

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Official Source

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