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FDA 510(k)

MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE

K-Number: K080530 · 2008-08-15

ApplicantCutera, Inc.
Decision Date2008-08-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2008-08-15 under 510(k) number K080530. 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 MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE?

MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE is a medical device that received FDA 510(k) clearance on 2008-08-15. The listed applicant is Cutera, Inc.. The 510(k) number is K080530.

When did MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE receive FDA 510(k) clearance?

MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE received FDA 510(k) clearance on 2008-08-15, under 510(k) number K080530.

Who is the listed applicant for MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE?

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

What is the FDA product code for MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE?

The FDA product code for MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE 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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