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FDA 510(k)

CUTERA ER:YAG LASER HANDPIECE

K-Number: K070138 · 2007-03-27

ApplicantCutera, Inc.
Decision Date2007-03-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUTERA ER:YAG 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 2007-03-27 under 510(k) number K070138. 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 CUTERA ER:YAG LASER HANDPIECE?

CUTERA ER:YAG LASER HANDPIECE is a medical device that received FDA 510(k) clearance on 2007-03-27. The listed applicant is Cutera, Inc.. The 510(k) number is K070138.

When did CUTERA ER:YAG LASER HANDPIECE receive FDA 510(k) clearance?

CUTERA ER:YAG LASER HANDPIECE received FDA 510(k) clearance on 2007-03-27, under 510(k) number K070138.

Who is the listed applicant for CUTERA ER:YAG 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 CUTERA ER:YAG LASER HANDPIECE?

The FDA product code for CUTERA ER:YAG 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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