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FDA 510(k)

CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT

K-Number: K050069 · 2005-01-31

ApplicantCutera, Inc.
Decision Date2005-01-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2005-01-31 under 510(k) number K050069. 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 FLASHLAMP TABLETOP AESTHETIC PRODUCT?

CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT is a medical device that received FDA 510(k) clearance on 2005-01-31. The listed applicant is Cutera, Inc.. The 510(k) number is K050069.

When did CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT receive FDA 510(k) clearance?

CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT received FDA 510(k) clearance on 2005-01-31, under 510(k) number K050069.

Who is the listed applicant for CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT?

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 FLASHLAMP TABLETOP AESTHETIC PRODUCT?

The FDA product code for CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT 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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